Cleared Traditional

K896465 - CLP CK/LD ISOENZYME/IMMUNO CONTROL

K896465 is the FDA 510(k) clearance for CLP CK/LD ISOENZYME/IMMUNO CONTROL by Creative Laboratory Products, Inc.. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K896465 · Creative Laboratory Products, Inc. · Chemistry device
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Mar 1990
Decision
108d
Days
Class 1
Risk

K896465 is an FDA 510(k) clearance for the CLP CK/LD ISOENZYME/IMMUNO CONTROL. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Creative Laboratory Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 1, 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 K896465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date March 01, 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 JJT Enzyme Controls (assayed And Unassayed)
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 - JJT Enzyme Controls (assayed And Unassayed)

All 59
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K896465.
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
K925151 · Bio-Rad · Dec 1992
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430 · Bio-Rad · Aug 1990
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
K902321 · Hichem Diagnostics · Jun 1990
CK-MB/LD-1 CONTROL SYSTEM
K894207 · Boehringer Mannheim Corp. · Aug 1989
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · Baxter Healthcare Corp · Aug 1988
QUANTIMETRIX SERUM ENZYME CONTROL
K880701 · Quantimetrix Corp. · Mar 1988