The acquired K142422 file contains product-specific indications and users, design and operating principle, recorded comparison and differences, non-clinical evidence actually described, clinical evidence or its stated absence sections. Compare these dated manufacturer statements with your own indication and design before commissioning evidence work. They describe this submission; they do not prescribe your testing, validate performance independently or establish a suitable predicate.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Source limits that change the comparison
A clinical section heading does not establish a patient study
The selected passage sits under “Clinical performance evaluation” but describes a multi-site reproducibility investigation using simulated clinical samples across lot, site/instrument, operator, day and within-run. That passage alone does not establish patient-enrollment evidence or clinical diagnostic performance. Other clinical evidence, if used, needs its own study population, specimen, comparator and denominator review. [6]
Prepare or ask: Separate this laboratory reproducibility design from any patient-specimen clinical study. Request the complete study sections and distinguish simulated samples, enrolled participants, specimen selection, comparator and exclusions before comparing performance.
Dated manufacturer-submitted summary; current buyer applicability remains unresolved. PDF page 17 ↗
The assay target, specimen and diagnostic-aid role are explicit
The recorded cobas Cdiff indication detects the toxin B (tcdB) gene of toxigenic C. difficile in unformed liquid or soft stool from patients suspected of CDI. It describes an aid to diagnosis alongside clinical and epidemiological risk factors; it is not a standalone clinical diagnosis or evidence for every specimen type. [2]
Prepare or ask: Compare proposed molecular target, specimen type, patient context and adjunctive claim. Keep those label facts separate from simulated-sample reproducibility and any patient-specimen clinical study.
Dated manufacturer-submitted summary; current buyer applicability remains unresolved. PDF page 3 ↗
Computed exact-code research
This decision beside its recorded product-code cohort
The 2021–2025 complete-year cohort contains 4 selected decisions under primary code OZN. 4 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
No quartiles are displayed: this complete-year cohort has fewer than 20 valid pairs.
The table shows the named decision and up to four latest exact-code research records through 2026-09-27. It can include partial-year records outside the complete-year cohort. The quartiles above use the full stated cohort, not this displayed selection.
| Research record | Recorded device | Receipt → decision | Calendar elapsed days | Recorded submission type |
|---|
| K142422 ↗ · this page | cobas Cdiff Test | 2014-08-28 → 2015-05-20 | 265 | Traditional |
|---|
| K260045 ↗ | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | 2026-01-07 → 2026-08-28 | 233 | Traditional |
|---|
| K243730 ↗ | Xpert C. difficile/Epi | 2024-12-03 → 2025-02-28 | 87 | Traditional |
|---|
| K232092 ↗ | Great Basin Toxigenic C. difficile Direct Test (CDF2) | 2023-07-13 → 2023-11-14 | 124 | Traditional |
|---|
| K212427 ↗ | cobas Cdiff nucleic acid test for use on the cobas Liat System | 2021-08-04 → 2021-10-20 | 77 | Special |
|---|
Use this comparison: select a record to investigate, read its actual indications and design, and document differences. A shared code or elapsed period cannot establish its relevance to your device.
Calendar elapsed days are not active FDA review time, a promised schedule or a success probability. The selection includes only the stated recorded decisions, not all applications. Latest records can postdate the named historical decision and are contextual research, not its predicates. Shared codes, summaries and observed records do not prove equivalence, current market availability, buyer applicability or predicate suitability.
Calculation, selection and source versions
Reuse the complete-endpoint exact-primary-code, documented SE-decision cohort and its stated cutoff/window. Retain its type-7 quartiles only when at least 20 valid date pairs are present. Independently subtract the named official record’s receipt date from its decision date; missing or negative pairs remain unknown. Show up to four latest exact-code research records, excluding the named ID. Parent analysis hash, source snapshots and calculation versions are retained.
Calculation: fda-named-decision-cohort-context-1; cutoff 2026-09-27; 0 parent records excluded; units record counts; calendar elapsed days.
Source snapshots: 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002.
Read beyond the decision row
Recorded evidence and differences to investigate
The summary is manufacturer-submitted context hosted by FDA. Negative/no-study statements are preserved. Evidence themes are not binding legal requirements.
Short opening excerpts identify the source sections. Read the linked original for the full study context, negative statements, tables and limitations. Public quotations are limited to 120 words per acquired summary; the internal evidence packet retains exact section ranges for review.
Indications and users
K142422 · PDF page 3 ↗ Source 2
Read this statement in the original PDF; no complete statement fits the short excerpt.
Compare with your product: Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
Design and operating principle
K142422 · PDF page 5 ↗ Source 3
Read this statement in the original PDF; no complete statement fits the short excerpt.
Compare with your product: Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
Recorded comparison and differences
K142422 · PDF page 7 ↗ Source 4
Read this statement in the original PDF; no complete statement fits the short excerpt.
Compare with your product: The summary’s comparison is a manufacturer statement about that submission. Investigate the actual design differences and cited records before considering any comparator or predicate.
Non-clinical evidence actually described
K142422 · PDF page 9 ↗ Source 5
Read this statement in the original PDF; no complete statement fits the short excerpt.
Compare with your product: Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.
Clinical evidence or its stated absence
K142422 · PDF page 17 ↗ Source 6
Read this statement in the original PDF; no complete statement fits the short excerpt.
Compare with your product: Preserve whether the summary describes clinical evidence or says none was performed. This recorded case does not determine whether your product needs clinical evidence.
Extraction selection and limits
Select observed whole-line section headings or explicit colon-delimited inline labels on readable PDF pages, including the explicitly documented heading-spacing variants in this parser version. Preserve the original heading, character ranges and layout; do not repair excerpt text. Exclude letter boilerplate and uncertain pages. Stop at observed table headings; do not infer table columns or scalar results from layout text. Multi-column or suspicious split-numeric excerpts are excluded until reviewed alternate extraction is available. Original layout records remain retained; any alternate text has its own extractor-version locator and requires original-page review. For each dimension, prefer usable versioned alternate text where available, selecting its longest usable excerpt; otherwise select the longest usable original-layout excerpt. Ties preserve source order. Bounded to 64 PDF pages and 3,500 characters per section. This is a selection, not a complete dossier analysis.
Excluded extraction items: {}.
