Cleared Traditional

K853009 - COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT

K853009 is an FDA 510(k) clearance for COBAS BACT ID TEST SYS, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code JSS cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K853009 · Roche Diagnostic Systems, Inc. · Microbiology device
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Mar 1986
Decision
231d
Days
Class 1
Risk

K853009 is an FDA 510(k) clearance for the COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Belleville, US). The FDA issued a Cleared decision on March 4, 1986 after a review of 231 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K853009

510(k) Number K853009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1985
Decision Date March 04, 1986
Days to Decision 231 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
129d slower than avg
Panel avg: 102d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

JSS Device Classification - Class 1, General Controls

Product Code JSS Kit, Identification, Enterobacteriaceae
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 - JSS Kit, Identification, Enterobacteriaceae

All 33
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K853009.
SENSITITRE INDOLE REAGENT
K894776 · Radiometer America, Inc. · Aug 1989
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558 · Vitek Systems, Inc. · Sep 1988
GI MOTILITY TEST MEDIUM W/TTC
K863603 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
RIM-UREA
K843571 · Austin Biological Laboratories · Oct 1984
TITERTEK ENTEROBAC*
K834090 · Flow Laboratories, Inc. · Jan 1984
SPECTRUM-10
K831672 · Austin Biological Laboratories · Jun 1983