Cleared Traditional

K934383 - PROLEX (STREPTOCCAL GROUPING LATEX KIT)

K934383 is an FDA 510(k) clearance for PROLEX (STREPTOCCAL GROUPING LATEX KIT), manufactured by Pro-Lab, Inc.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 505-day FDA review.

K934383 · Pro-Lab, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
505d
Days
Class 1
Risk

K934383 is an FDA 510(k) clearance for the PROLEX (STREPTOCCAL GROUPING LATEX KIT). Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Pro-Lab, Inc. (Richmond Hill, Ontario, CA). The FDA issued a Cleared decision on January 27, 1995 after a review of 505 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Pro-Lab, Inc. devices

FDA 510(k) Submission Details - K934383

510(k) Number K934383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1993
Decision Date January 27, 1995
Days to Decision 505 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
403d slower than avg
Panel avg: 102d · This submission: 505d
Pathway characteristics
Predicate-based equivalence.

GTZ Device Classification - Class 1, General Controls

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 89
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K934383.
QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
K935475 · Syntron Bioresearch, Inc. · Aug 1995
QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
K935554 · Syntron Bioresearch, Inc. · Aug 1995
ABBOTT TEST PACK STREP A TEST
K945571 · Abbott Laboratories · Aug 1995
REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
K942093 · Medical Diagnostic Technologies, Inc. · Nov 1994
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
K932482 · Medix Biotech, Inc. · Jul 1994
QUICKVUE IN-LINE ONE-STEP STREP A TEST
K934484 · Quidel Corp. · Jul 1994