Cleared Traditional

K972904 - DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA ...

K972904 is the FDA 510(k) clearance for DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA ... by Casco Standards. It is a Class 1 Microbiology device (product code JJY) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K972904 · Casco Standards · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
198d
Days
Class 1
Risk

K972904 is an FDA 510(k) clearance for the DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on February 20, 1998 after a review of 198 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Casco Standards devices

Submission Details

510(k) Number K972904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1997
Decision Date February 20, 1998
Days to Decision 198 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 102d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

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