Cleared Traditional

K971636 - RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY...

K971636 is an FDA 510(k) clearance for RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY..., manufactured by Oxoid , Ltd.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K971636 · Oxoid , Ltd. · Microbiology device
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Jan 1998
Decision
271d
Days
Class 2
Risk

K971636 is an FDA 510(k) clearance for the RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on January 28, 1998 after a review of 271 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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 Oxoid , Ltd. devices

FDA 510(k) Submission Details - K971636

510(k) Number K971636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date January 28, 1998
Days to Decision 271 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 102d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTN Device Classification - Class 2, Special Controls

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 313
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K971636.
PASCO MIC AND MIC/ID PANELS
K980955 · Pasco Laboratories, Inc. · May 1998
TROVAFLOXACIN 10G, SENSI-DISC
K980683 · Becton Dickinson Microbiology Systems · May 1998
GREPAFLOXACIN, 5 MG, SENSI-DISC
K974578 · Becton Dickinson Microbiology Systems · Feb 1998
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K974394 · Oxoid , Ltd. · Jan 1998
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971637 · Oxoid , Ltd. · Dec 1997
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973479 · Oxoid , Ltd. · Dec 1997