Cleared Traditional

K902037 - PATHODX PYR KIT

K902037 is the FDA 510(k) clearance for PATHODX PYR KIT by Diagnostic Products Corp.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K902037 · Diagnostic Products Corp. · Microbiology device
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Jun 1990
Decision
28d
Days
Class 1
Risk

K902037 is an FDA 510(k) clearance for the PATHODX PYR KIT. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 1, 1990 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K902037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1990
Decision Date June 01, 1990
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 139
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K902037.
VANCOMYCIN DISK-5 MCG
K905151 · Remel Co. · Jan 1991
CATARRHALIS TEST STRIP
K902595 · Remel Co. · Oct 1990
DRYSLIDE, BETA-LACTAMASE
K901784 · Difco Laboratories, Inc. · Jun 1990
DMAC INDOLE REAGENT
K901390 · Analytical Products, Inc. · Apr 1990
DIFCO OXIDASE DRYSLIDE
K896398 · Difco Laboratories, Inc. · Dec 1989
PYR/ESCULIN DISK
K880950 · Remel Co. · Apr 1988