Cleared Traditional

K834389 - AMS GRAM-POSITIVE IDENT. CARD

K834389 is the FDA 510(k) clearance for AMS GRAM-POSITIVE 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 86-day FDA review.

K834389 · Vitek Systems, Inc. · Microbiology device
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Mar 1984
Decision
86d
Days
Class 1
Risk

K834389 is an FDA 510(k) clearance for the AMS GRAM-POSITIVE 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 86 days - a notably fast clearance cycle.

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: 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 Vitek Systems, Inc. devices

Submission Details

510(k) Number K834389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date March 09, 1984
Days to Decision 86 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
16d faster than avg
Panel avg: 102d · This submission: 86d
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 K834389.
MICRODASE
K840819 · Remel Co. · Mar 1984
DIFFERENTIATION DISKS ALA
K840896 · Difco Laboratories, Inc. · Mar 1984
AMS GRAM-NEGATIVE IDENT. CARD
K834269 · Vitek Systems, Inc. · Mar 1984
DISCS
K840028 · Anaerobe Systems · Mar 1984
STRIPS
K840029 · Anaerobe Systems · Mar 1984
REAGENTS
K840030 · Anaerobe Systems · Mar 1984