Cleared Traditional

K925969 - ADAMS SCIENTIFIC SENSITIVITY DISCS

K925969 is an FDA 510(k) clearance for ADAMS SCIENTIFIC SENSITIVITY DISCS, manufactured by Adams Scientific, Inc.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K925969 · Adams Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
79d
Days
Class 2
Risk

K925969 is an FDA 510(k) clearance for the ADAMS SCIENTIFIC SENSITIVITY DISCS. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Adams Scientific, Inc. (West Warwick, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 79 days - a notably fast clearance 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: 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 Adams Scientific, Inc. devices

FDA 510(k) Submission Details - K925969

510(k) Number K925969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date February 12, 1993
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 102d · This submission: 79d
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 314
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K925969.
BILE SPOT REAGENT
K931530 · Hardy Diagnostics · May 1993
DISPENS-O-DISC CLARITHROMYCIN 15 MG.
K930911 · Difco Laboratories, Inc. · Apr 1993
DISPENS-O-DISC CEFPODOXIME 10 MCG.
K930946 · Difco Laboratories, Inc. · Apr 1993
REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK
K925060 · Remel Co. · Dec 1992
REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK
K924846 · Remel Co. · Nov 1992
CEFPODOXIME 10 MCG, SENSI DISC
K924797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1992