Cleared Traditional

K895139 - CLINISTAT HDL CHOLESTEROL REAGENT TEST

K895139 is an FDA 510(k) clearance for CLINISTAT HDL CHOLESTEROL REAGENT TEST, manufactured by Heraeus Kulzer, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K895139 · Heraeus Kulzer, Inc. · Chemistry device
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Dec 1989
Decision
133d
Days
Class 1
Risk

K895139 is an FDA 510(k) clearance for the CLINISTAT HDL CHOLESTEROL REAGENT TEST. 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 December 27, 1989 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K895139

510(k) Number K895139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1989
Decision Date December 27, 1989
Days to Decision 133 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 slower than avg
Panel avg: 88d · This submission: 133d
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 73
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K895139.
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511 · Technicon Instruments Corp. · Nov 1991
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
K905296 · Cholestech Corp. · Dec 1990
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · Immunotech Corp. · Mar 1990
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851 · Beckman Instruments, Inc. · Nov 1989
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
K893548 · Heraeus Kulzer, Inc. · Aug 1989
IQ HDL CHOLESTEROL
K881891 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988