Cleared Traditional

K860485 - SGPT (ALT) REAGENT SET (COLORIMETRIC)

K860485 is an FDA 510(k) clearance for SGPT (ALT) REAGENT SET (COLORIMETRIC), manufactured by Sterling Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CKD cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K860485 · Sterling Diagnostics, Inc. · Chemistry device
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Apr 1986
Decision
52d
Days
Class 1
Risk

K860485 is an FDA 510(k) clearance for the SGPT (ALT) REAGENT SET (COLORIMETRIC). Classified as Hydrazone Colorimetry, Alt/sgpt (product code CKD), Class I - General Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on April 3, 1986 after a review of 52 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 Sterling Diagnostics, Inc. devices

FDA 510(k) Submission Details - K860485

510(k) Number K860485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1986
Decision Date April 03, 1986
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

CKD Device Classification - Class 1, General Controls

Product Code CKD Hydrazone Colorimetry, 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 - CKD Hydrazone Colorimetry, Alt/sgpt

All 8
Devices cleared under the same product code (CKD) and FDA review panel - the closest regulatory comparables to K860485.
COBAS READY ALT REAGENT
K896237 · Roche Diagnostic Systems, Inc. · Feb 1990
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
K883387 · Tech-Co, Inc. · Oct 1988
REFLOTRON(R) ALT (GPT)
K864082 · Boehringer Mannheim Corp. · Dec 1986
SGPT REAGENT SET
K841059 · Medical Specialties, Inc. · May 1984
SGPT REAGENT SET
K821207 · Omega Medical Electronics · Jul 1982
SGPT REAGENT SET
K820491 · Anco Medical Reagents & Assoc. · Mar 1982