Cleared Traditional

K852871 - IDS RAPID SS/U SYSTEM

K852871 is an FDA 510(k) clearance for IDS RAPID SS/U SYSTEM, manufactured by Innovative Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code JSS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K852871 · Innovative Diagnostic Systems, Inc. · Microbiology device
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Jul 1985
Decision
15d
Days
Class 1
Risk

K852871 is an FDA 510(k) clearance for the IDS RAPID SS/U SYSTEM. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on July 23, 1985 after a review of 15 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.

FDA 510(k) Submission Details - K852871

510(k) Number K852871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1985
Decision Date July 23, 1985
Days to Decision 15 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
87d faster than avg
Panel avg: 102d · This submission: 15d
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 48
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K852871.
API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)
K854733 · Dms Products, Inc. · Mar 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · Roche Diagnostic Systems, Inc. · Mar 1986
QUADRA-TITER I.D.
K860208 · Microtech Medical Systems, Inc. · Mar 1986
LYFO-KWIK OMI KIT
K851978 · Micro-Bio-Logics · Jun 1985
IDS RAPID E PLUS SYSTEM
K852110 · Innovative Diagnostic Systems, Inc. · Jun 1985
RIM-UREA
K843571 · Austin Biological Laboratories · Oct 1984
K852871 · IDS RAPID SS/U SYSTEM
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