Cleared Traditional

K801159 - STREPTO-SEC TM

K801159 is an FDA 510(k) clearance for STREPTO-SEC TM, manufactured by Organon, Inc.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K801159 · Organon, Inc. · Microbiology device
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Jun 1980
Decision
40d
Days
Class 1
Risk

K801159 is an FDA 510(k) clearance for the STREPTO-SEC TM. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Organon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1980 after a review of 40 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 Organon, Inc. devices

FDA 510(k) Submission Details - K801159

510(k) Number K801159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1980
Decision Date June 20, 1980
Days to Decision 40 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
62d faster than avg
Panel avg: 102d · This submission: 40d
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 K801159.
ABBOTT LABORATORIES STREP A EIA
K823569 · Abbott Laboratories · Mar 1983
MERITECASTREP (TM)
K821100 · Meridian Diagnostics, Inc. · May 1982
WELLCOGEN GROUP B
K820069 · Burroughs Wellcome Co. · Feb 1982
PHADEBACT STREP D TEST
K800159 · Pharmacia, Inc. · Apr 1980
STREP-TEX
K781607 · Burroughs Wellcome Co. · Oct 1978
TEST, ANTIBODIES FOR GRP A, LATEX SLIDE
K760033 · Gamma Biologicals, Inc. · Aug 1976