Cleared Traditional

K971526 - ACE HDL-C REAGENT

K971526 is an FDA 510(k) clearance for ACE HDL-C REAGENT, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K971526 · Schiapparelli Biosystems, Inc. · Chemistry device
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May 1997
Decision
23d
Days
Class 1
Risk

K971526 is an FDA 510(k) clearance for the ACE HDL-C REAGENT. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 21, 1997 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Schiapparelli Biosystems, Inc. devices

FDA 510(k) Submission Details - K971526

510(k) Number K971526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date May 21, 1997
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

LBS Device Classification - Class 1, General Controls

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 53
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K971526.
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K971190 · Genzyme Corp. · Jun 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · Roche Diagnostic Systems, Inc. · Jun 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735 · Randox Laboratories, Ltd. · Jun 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
HDL QVET
K943028 · Prisma Systems · Dec 1994
BECKMAN HDL CHOLESTEROL REAGENT
K934045 · Beckman Instruments, Inc. · Oct 1993