Cleared Traditional

K842383 - PATHO DX LATEX AGGLUTINATION STREP A

K842383 is the FDA 510(k) clearance for PATHO DX LATEX AGGLUTINATION STREP A by Diagnostic Products Corp.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K842383 · Diagnostic Products Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
14d
Days
Class 1
Risk

K842383 is an FDA 510(k) clearance for the PATHO DX LATEX AGGLUTINATION STREP A. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1984 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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 K842383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1984
Decision Date July 02, 1984
Days to Decision 14 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
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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 - GTZ Antisera, All Groups, Streptococcus Spp.

All 55
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K842383.
VENTRESCREEN STREP A TEST
K844855 · Ventrex Laboratories, Inc. · Jan 1985
DIRECTIGEN GROUP A STREP TEST KIT
K843713 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
PHARMACIA STREP A DIRECT SWAB TEST
K844107 · Pharmacia, Inc. · Nov 1984
DETECT GROUP A STREP TEST
K834582 · Difco Laboratories, Inc. · Apr 1984
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
K831991 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
PHADEBACT STREP F TEST
K830445 · Pharmacia, Inc. · Apr 1983