Cleared Traditional

K913846 - ABBOTT QUICKSTART ALANINE AMINOTRANSFER

K913846 is the FDA 510(k) clearance for ABBOTT QUICKSTART ALANINE AMINOTRANSFER by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K913846 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
22d
Days
Class 1
Risk

K913846 is an FDA 510(k) clearance for the ABBOTT QUICKSTART ALANINE AMINOTRANSFER. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 19, 1991 after a review of 22 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K913846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1991
Decision Date September 19, 1991
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
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: 88d · This submission: 22d
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 97
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K913846.
SYNERMED ALT/GPT REAGENT KIT
K921016 · Synermed, Inc. · May 1992
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
K920335 · Heraeus Kulzer, Inc. · Mar 1992
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464 · Em Diagnostic Systems, Inc. · Nov 1991
COULTER DART ALT (GPT) REAGENT
K905767 · Coulter Electronics, Inc. · Jan 1991
ALANINE AMINOTRANSFERASE TEST
K903198 · Em Diagnostic Systems, Inc. · Sep 1990
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K901702 · American Research Products Co. · Apr 1990