Cleared Traditional

K840705 - PARAMAX ALANINE AMINOTRANSFERASE

K840705 is the FDA 510(k) clearance for PARAMAX ALANINE AMINOTRANSFERASE by American Dade. It is a Class 1 Hematology device (product code CKA) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K840705 · American Dade · Hematology device
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Mar 1984
Decision
21d
Days
Class 1
Risk

K840705 is an FDA 510(k) clearance for the PARAMAX ALANINE AMINOTRANSFERASE. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1030 - the FDA hematology 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 American Dade devices

Submission Details

510(k) Number K840705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1984
Decision Date March 09, 1984
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
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 98
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K840705.
SIGMA 59-UV FOR ALANINE AMINOTRANSFER
K842564 · Sigma Chemical Co. · Aug 1984
ALANINE AMINOTRANSFERASE ASSAY KIT
K842241 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
SGPT REAGENT SET
K841060 · Medical Specialties, Inc. · May 1984
ALT -LTS
K832639 · Electro-Nucleonics Laboratories, Inc. · Sep 1983
FLOW-PAC SGPT REAGENT
K830959 · Amresco, Inc. · May 1983
ALT ENZYME ASSAY KIT
K821946 · Travenol Laboratories, S.A. · Jul 1982