Cleared Traditional

K844159 - API UNISCEPT MIC 100UL

K844159 is an FDA 510(k) clearance for API UNISCEPT MIC 100UL, manufactured by Analytical Products, Inc.. The device is a Class 2 Microbiology device with product code LTW cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K844159 · Analytical Products, Inc. · Microbiology device
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Dec 1984
Decision
51d
Days
Class 2
Risk

K844159 is an FDA 510(k) clearance for the API UNISCEPT MIC 100UL. Classified as Susceptibility Test Cards, Antimicrobial (product code LTW), Class II - Special Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on December 14, 1984 after a review of 51 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 - K844159

510(k) Number K844159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1984
Decision Date December 14, 1984
Days to Decision 51 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
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTW Device Classification - Class 2, Special Controls

Product Code LTW Susceptibility Test Cards, 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 - LTW Susceptibility Test Cards, Antimicrobial

All 14
Devices cleared under the same product code (LTW) and FDA review panel - the closest regulatory comparables to K844159.
PRECEPT ERYTHROMYCIN
K853053 · Austin Biological Laboratories · Aug 1985
PRECEPT AVGMENTIN
K853263 · Austin Biological Laboratories · Aug 1985
API UNISCEPT KB
K850347 · Analytical Products, Inc. · Mar 1985
SCEPTOR BETA-LACTAM PLUS MIC PANEL
K844231 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1984
API UNISCEPT KB
K843733 · Analytical Products, Inc. · Oct 1984