Cleared Traditional

DADE(R) CK-MB IMMUNOASSAY CONTROL (K882795) - FDA 510(k) Clearance

Class I Chemistry device.

K882795 · Baxter Healthcare Corp · Chemistry device
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Aug 1988
Decision
54d
Days
Class 1
Risk

K882795 is an FDA 510(k) clearance for the DADE(R) CK-MB IMMUNOASSAY CONTROL. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on August 29, 1988 after a review of 54 days - a notably fast clearance cycle.

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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K882795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1988
Decision Date August 29, 1988
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
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 28
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K882795.
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
K925151 · Bio-Rad · Dec 1992
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430 · Bio-Rad · Aug 1990
CK-MB/LD-1 CONTROL SYSTEM
K894207 · Boehringer Mannheim Corp. · Aug 1989
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · Helena Laboratories · Nov 1987
VIRON(TM)
K872646 · bioMerieux, Inc. · Sep 1987
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512 · Em Diagnostic Systems, Inc. · May 1986