Cleared Traditional

K834269 - AMS GRAM-NEGATIVE IDENT. CARD

K834269 is the FDA 510(k) clearance for AMS GRAM-NEGATIVE IDENT. CARD by Vitek Systems, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K834269 · Vitek Systems, Inc. · Microbiology device
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Mar 1984
Decision
92d
Days
Class 1
Risk

K834269 is an FDA 510(k) clearance for the AMS GRAM-NEGATIVE IDENT. 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 March 9, 1984 after a review of 92 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 K834269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date March 09, 1984
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
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 K834269.
DIFFERENTIATION DISKS SPS
K840804 · Difco Laboratories, Inc. · Mar 1984
MICRODASE
K840819 · Remel Co. · Mar 1984
DIFFERENTIATION DISKS ALA
K840896 · Difco Laboratories, Inc. · Mar 1984
AMS GRAM-POSITIVE IDENT. CARD
K834389 · Vitek Systems, Inc. · Mar 1984
DISCS
K840028 · Anaerobe Systems · Mar 1984
STRIPS
K840029 · Anaerobe Systems · Mar 1984