Cleared Traditional

K855028 - TOTAL CHOLESTEROL REAGENT SET

K855028 is the FDA 510(k) clearance for TOTAL CHOLESTEROL REAGENT SET by Sterling Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K855028 · Sterling Diagnostics, Inc. · Chemistry device
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Jan 1986
Decision
43d
Days
Class 1
Risk

K855028 is an FDA 510(k) clearance for the TOTAL CHOLESTEROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on January 28, 1986 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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

Submission Details

510(k) Number K855028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1985
Decision Date January 28, 1986
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 126
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K855028.
CHOLESTEROL PROCEDURE
K861659 · Data Medical Associates, Inc. · Jun 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K861700 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1986
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)
K860717 · Trace Scientific , Ltd. · Apr 1986
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426 · Eastman Kodak Company · Jan 1986
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K854179 · Clinical Data, Inc. · Nov 1985
ASTRA SYSTEMS CHOLESTEROL REAGENT
K853854 · Beckman Instruments, Inc. · Oct 1985