Cleared Traditional

DIPSTICK SALMONELLA (K910438) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910438 · Ampcor, Inc. · Microbiology device
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Sep 1991
Decision
225d
Days
Class 2
Risk

K910438 is an FDA 510(k) clearance for the DIPSTICK SALMONELLA. Classified as Antisera, All Groups, Salmonella Spp. (product code GRM), Class II - Special Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 225 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ampcor, Inc. devices

Submission Details

510(k) Number K910438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1991
Decision Date September 13, 1991
Days to Decision 225 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 102d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (GRM) and FDA review panel - the closest regulatory comparables to K910438.
SAS SALMONELLA O FACTOR 20 ANTISERUM
K961948 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA O FACTOR 14 ANTISERUM
K961949 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
K961950 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA O FACTOR 6 ANTISERUM
K961951 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
K961952 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELA H Z24 ANTISERUM
K961953 · Sa Scientific, Inc. · Jun 1996