Cleared Traditional

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN (K983310) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983310 · Accumed Intl., Inc. · Microbiology device
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Dec 1998
Decision
87d
Days
Class 2
Risk

K983310 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN. Classified as Susceptibility Test Powders, Antimicrobial (product code JTT), Class II - Special Controls.

Submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on December 17, 1998 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Accumed Intl., Inc. devices

Submission Details

510(k) Number K983310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1998
Decision Date December 17, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTT Susceptibility Test Powders, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - JTT Susceptibility Test Powders, Antimicrobial

All 13
Devices cleared under the same product code (JTT) and FDA review panel - the closest regulatory comparables to K983310.
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
K895362 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
K855106 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1986
ANTITUBERCULOUS DRUGS (SIRE)
K822329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982