Cleared Traditional

K861231 - ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)

K861231 is the FDA 510(k) clearance for ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) by Hi Chem, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K861231 · Hi Chem, Inc. · Chemistry device
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Apr 1986
Decision
27d
Days
Class 1
Risk

K861231 is an FDA 510(k) clearance for the ALT REAGENT CARTRIDGE (PRODUCT NO. 88210). Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on April 28, 1986 after a review of 27 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 Hi Chem, Inc. devices

Submission Details

510(k) Number K861231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1986
Decision Date April 28, 1986
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 K861231.
TWIN GOT-AST IFCC/GPT-ALT IFCC
K861792 · Boehringer Mannheim Corp. · Jul 1986
ALT (SGPT) REAGENT SET (UV RATE)
K862209 · Sterling Diagnostics, Inc. · Jun 1986
ALT/GPT PROCEDURE
K861658 · Data Medical Associates, Inc. · May 1986
VISION SGPT (ALT)
K861002 · Abbott Laboratories · Apr 1986
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT
K860727 · Trace Scientific , Ltd. · Apr 1986
IN VITRO TEST DETERMINATION OF SGPT(ALT)
K854186 · Clinical Data, Inc. · Dec 1985