Cleared Traditional

PARAMAX ALANINE AMINOTRANSFERASE REAGENT (K901105) - FDA 510(k) Clearance

Class I Chemistry device.

K901105 · Baxter Healthcare Corp · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
15d
Days
Class 1
Risk

K901105 is an FDA 510(k) clearance for the PARAMAX ALANINE AMINOTRANSFERASE REAGENT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 23, 1990 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - the FDA in vitro diagnostics and chemistry 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K901105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1990
Decision Date March 23, 1990
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 31
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K901105.
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464 · Em Diagnostic Systems, Inc. · Nov 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
K913846 · Em Diagnostic Systems, Inc. · Sep 1991
ALANINE AMINOTRANSFERASE TEST
K903198 · Em Diagnostic Systems, Inc. · Sep 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234 · Roche Diagnostic Systems, Inc. · Feb 1990
ALT REAGENT (PROCEDURE NUMBER 159)
K893560 · Sigma Chemical Co. · Jul 1989
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
K893752 · Em Diagnostic Systems, Inc. · Jul 1989