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K Number
K053287
Device Name
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2006-08-10

(258 days)

Product Code
MKZ
Regulation Number
866.3120
Type
Traditional
Panel
MI
Reference & Predicate Devices
K973718
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Roche Scripts for COBAS AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:

  • COBAS AMPLICOR™ CT/NG test for Chlamydia trachomatis
  • COBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae
Device Description

The Roche Scripts for COBAS AMPLICOR CT/NG Test accessory consists of a compact disc (CDs) containing scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis.

AI/ML Overview

The provided text describes a 510(k) summary for the COBAS AMPLICOR CT/NG test for Chlamydia trachomatis with Roche Scripts Accessory. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document mainly focuses on:

  • Device description and intended use of the COBAS AMPLICOR CT/NG test.
  • Description of the Roche Scripts accessory (software) to automate sample processing.
  • Comparison to a predicate device.
  • The FDA's decision letter for 510(k) clearance, confirming substantial equivalence.
  • Indications for Use for the Roche Scripts accessory.

There is no mention of:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets, data provenance.
  3. Number of experts or their qualifications for ground truthing.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or a study that proves the device meets the acceptance criteria, as this information is not present in the document. The document primarily focuses on the description and intended use of the device and its 510(k) clearance.

§ 866.3120 Chlamydia serological reagents.

(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).