Cleared Traditional

K822144 - IDS STAPHYLOCHROME TEST

K822144 is the FDA 510(k) clearance for IDS STAPHYLOCHROME TEST by Innovative Diagnostic Systems, Inc.. It is a Class 1 Microbiology device (product code JWX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K822144 · Innovative Diagnostic Systems, Inc. · Microbiology device
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Aug 1982
Decision
34d
Days
Class 1
Risk

K822144 is an FDA 510(k) clearance for the IDS STAPHYLOCHROME TEST. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 24, 1982 after a review of 34 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 Innovative Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K822144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1982
Decision Date August 24, 1982
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JWX Kit, Screening, Staphylococcus Aureus
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 - JWX Kit, Screening, Staphylococcus Aureus

All 7
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K822144.
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · Orthomet, Inc. · Jun 1990
BACTO STAPHYLOCOCCUS LATEX TEST
K843560 · Difco Laboratories, Inc. · Oct 1984
LSM AGAR
K822558 · Granite Diagnostics, Inc. · Sep 1982
BBL STAPHYSLIDE TEST
K821962 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1982