Cleared Traditional

K820264 - AMS GRAM-POSITIVE IDENTIFICATION CARD

K820264 is the FDA 510(k) clearance for AMS GRAM-POSITIVE IDENTIFICATION CARD by Vitek Systems, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K820264 · Vitek Systems, Inc. · Microbiology device
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May 1982
Decision
90d
Days
Class 1
Risk

K820264 is an FDA 510(k) clearance for the AMS GRAM-POSITIVE IDENTIFICATION CARD. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1982 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Vitek Systems, Inc. devices

Submission Details

510(k) Number K820264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1982
Decision Date May 03, 1982
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 147
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K820264.
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP
K823718 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1983
BACTEC NAP TB DIFFERENTIATION TEST
K822946 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1982
NEIDENT*
K821907 · Analytical Products, Inc. · Jul 1982
METRONIDAZOLE DIAGNOSTIC DISCS
K813509 · Oxoid U.S.A., Inc. · Dec 1981
CEFINASE TM DISCS
K813442 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
MS-2 BACTERIAL IDENTIFICATION SYS
K813031 · Abbott Laboratories · Dec 1981