Cleared Traditional

K896109 - IMMUNOCARD STREP A TEST

K896109 is the FDA 510(k) clearance for IMMUNOCARD STREP A TEST by Disease Detection International, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K896109 · Disease Detection International, Inc. · Microbiology device
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Nov 1989
Decision
37d
Days
Class 1
Risk

K896109 is an FDA 510(k) clearance for the IMMUNOCARD STREP A TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on November 29, 1989 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 Disease Detection International, Inc. devices

Submission Details

510(k) Number K896109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1989
Decision Date November 29, 1989
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
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 63
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K896109.
QUIDEL GROUP B STREP TEST
K896265 · Quidel Corp. · Feb 1990
VENTRESIGN STREP A TEST
K897083 · Ventrex Laboratories, Inc. · Jan 1990
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
K895103 · Gen-Probe, Inc. · Nov 1989
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
K894711 · Gen-Probe, Inc. · Nov 1989
LEECO VIS-DISK STREP-A (EIA)
K894122 · Leeco Diagnostics, Inc. · Aug 1989
CLEARVIEW STREP A
K893422 · Unipath , Ltd. · Jun 1989