Cleared Traditional

K896221 - CARDS O.S.(TM) STREP A

K896221 is the FDA 510(k) clearance for CARDS O.S.(TM) STREP A by Pacific Biotech, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K896221 · Pacific Biotech, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
44d
Days
Class 1
Risk

K896221 is an FDA 510(k) clearance for the CARDS O.S.(TM) STREP A. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Pacific Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 13, 1989 after a review of 44 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 Pacific Biotech, Inc. devices

Submission Details

510(k) Number K896221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date December 13, 1989
Days to Decision 44 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 102d · This submission: 44d
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 K896221.
TESTPACK PLUS STREP A
K901274 · Abbott Laboratories · May 1990
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