Cleared Traditional

K860369 - API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC

K860369 is an FDA 510(k) clearance for API UNISCEPT MICRO-MIC CEFTRIAXONE/UNIS..., manufactured by Analytical Products, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K860369 · Analytical Products, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
36d
Days
Class 2
Risk

K860369 is an FDA 510(k) clearance for the API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on March 11, 1986 after a review of 36 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 Analytical Products, Inc. devices

FDA 510(k) Submission Details - K860369

510(k) Number K860369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1986
Decision Date March 11, 1986
Days to Decision 36 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
66d faster than avg
Panel avg: 102d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 394
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K860369.
SENSITITRE SUSCEPTIBILITY PLATES
K860753 · Gibco Laboratories Life Technologies, Inc. · May 1986
FOX FASTIDIOUS TEST PANEL
K854525 · Beckman Instruments, Inc. · Apr 1986
MICRO-MEDIA MICRODILUTION TEST PANELS
K853805 · Beckman Instruments, Inc. · Mar 1986
PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE
K860195 · Austin Biological Laboratories · Feb 1986
PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
K854577 · Austin Biological Laboratories · Feb 1986
PASCO RESISTANT 5 PANEL
K853862 · Pasco Laboratories, Inc. · Jan 1986