Cleared Traditional

K895862 - CLP NORMAL LIPID CONTROL

K895862 is the FDA 510(k) clearance for CLP NORMAL LIPID CONTROL by Creative Laboratory Products, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K895862 · Creative Laboratory Products, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
108d
Days
Class 1
Risk

K895862 is an FDA 510(k) clearance for the CLP NORMAL LIPID CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Creative Laboratory Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Creative Laboratory Products, Inc. devices

Submission Details

510(k) Number K895862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date January 19, 1990
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 469
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K895862.
MULTICONSTITUENT SERUM RANGE LINEARITY #88234
K901115 · Hichem Diagnostics · Apr 1990
CHEM-CHEX
K900993 · Streck Laboratories, Inc. · Apr 1990
DADE(R) TDM CONTROL
K892642 · Baxter Healthcare Corp · Feb 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905 · Bio-Rad · Jan 1990
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY
K896522 · Casco Standards · Jan 1990
NORMAL AND ABNORMAL CONTROL SERA
K895943 · Sclavo, Inc. · Dec 1989