Cleared Traditional

K871831 - PATHO DX LATEX AGGLUTINATION STREP GROU...

K871831 is the FDA 510(k) clearance for PATHO DX LATEX AGGLUTINATION STREP GROU... by Diagnostic Products Corp.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K871831 · Diagnostic Products Corp. · Microbiology device
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Jun 1987
Decision
37d
Days
Class 1
Risk

K871831 is an FDA 510(k) clearance for the PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 17, 1987 after a review of 37 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 K871831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1987
Decision Date June 17, 1987
Days to Decision 37 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
65d faster than avg
Panel avg: 102d · This submission: 37d
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 K871831.
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