Cleared Traditional

K912791 - SALMONELLA O GROUPING ANTISERA SET

K912791 is an FDA 510(k) clearance for SALMONELLA O GROUPING ANTISERA SET, manufactured by S.M.I. Medical, Inc.. The device is a Class 2 Microbiology device with product code GRM cleared through the Traditional 510(k) pathway after a 468-day FDA review.

K912791 · S.M.I. Medical, Inc. · Microbiology device
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Oct 1992
Decision
468d
Days
Class 2
Risk

K912791 is an FDA 510(k) clearance for the SALMONELLA O GROUPING ANTISERA SET. Classified as Antisera, All Groups, Salmonella Spp. (product code GRM), Class II - Special Controls.

Submitted by S.M.I. Medical, Inc. (Avon, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3550 - 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 S.M.I. Medical, Inc. devices

FDA 510(k) Submission Details - K912791

510(k) Number K912791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date October 05, 1992
Days to Decision 468 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
366d slower than avg
Panel avg: 102d · This submission: 468d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GRM Device Classification - Class 2, Special Controls

Product Code GRM Antisera, All Groups, Salmonella Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GRM Antisera, All Groups, Salmonella Spp.

All 67
Devices cleared under the same product code (GRM) and FDA review panel - the closest regulatory comparables to K912791.
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