Cleared Traditional

SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP (K893548) - FDA 510(k) Clearance

Class I Chemistry device.

K893548 · Heraeus Kulzer, Inc. · Chemistry device
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Aug 1989
Decision
87d
Days
Class 1
Risk

K893548 is an FDA 510(k) clearance for the SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 87 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K893548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date August 03, 1989
Days to Decision 87 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
1d faster than avg
Panel avg: 88d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 27
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K893548.
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511 · Technicon Instruments Corp. · Nov 1991
CLINISTAT HDL CHOLESTEROL REAGENT TEST
K895139 · Heraeus Kulzer, Inc. · Dec 1989
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851 · Beckman Instruments, Inc. · Nov 1989
IQ HDL CHOLESTEROL
K881891 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397 · Em Diagnostic Systems, Inc. · Nov 1987
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1987