Cleared Traditional

K771586 - CHOLOPAP-HDL

K771586 is the FDA 510(k) clearance for CHOLOPAP-HDL by Advanced Biomedical Methods, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K771586 · Advanced Biomedical Methods, Inc. · Chemistry device
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Sep 1977
Decision
28d
Days
Class 1
Risk

K771586 is an FDA 510(k) clearance for the CHOLOPAP-HDL. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Advanced Biomedical Methods, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 15, 1977 after a review of 28 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 Advanced Biomedical Methods, Inc. devices

Submission Details

510(k) Number K771586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1977
Decision Date September 15, 1977
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 129
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K771586.
ULTRACHEM ENZYMATIC CHOLESTEROL 65025
K780523 · Harleco · May 1978
REAGENT SET HDL CHOLESTEROL
K780635 · Boehringer Mannheim Corp. · May 1978
CHOLAR PRODU&T #17010
K771731 · Hi Chem, Inc. · Oct 1977
MULTISTAT III CHOLESTEROL TEST
K771508 · Instrumentation Laboratory CO · Sep 1977
HOLESTEROL DELTA TEST ASSAY
K771582 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977
ENZYMATIC CHOLESTEROL REAGENT SET
K770909 · American Monitor Corp. · Jul 1977