Cleared Traditional

K864244 - GARNERELLA VAGINALIS IDENTIFICATION KIT

K864244 is an FDA 510(k) clearance for GARNERELLA VAGINALIS IDENTIFICATION KIT, manufactured by Mds Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K864244 · Mds Laboratories, Inc. · Microbiology device
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Mar 1987
Decision
154d
Days
Class 1
Risk

K864244 is an FDA 510(k) clearance for the GARNERELLA VAGINALIS IDENTIFICATION KIT. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987 after a review of 154 days - an extended review 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: 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 Mds Laboratories, Inc. devices

FDA 510(k) Submission Details - K864244

510(k) Number K864244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 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
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

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 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K864244.
GEN-PROBE BETA-LACTAMASE TEST KIT
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SPOTTEST 10% SODIUM DESOXYCHOLATE
K870716 · Difco Laboratories, Inc. · Apr 1987
SPOTTEST MICRODASE
K870717 · Difco Laboratories, Inc. · Apr 1987
SPOTTEST PYR REAGENT
K870449 · Difco Laboratories, Inc. · Feb 1987
ONPG SOLUTION
K863601 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
NEIS NZY
K863216 · Carr-Scarborough Microbiologicals, Inc. · Sep 1986