Cleared Traditional

ISOSCREEN-CK CONFIRMATORY KIT (K895870) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895870 · Roche Diagnostic Systems, Inc. · Chemistry device
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Dec 1989
Decision
58d
Days
Class 2
Risk

K895870 is an FDA 510(k) clearance for the ISOSCREEN-CK CONFIRMATORY KIT. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on December 1, 1989 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K895870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1989
Decision Date December 01, 1989
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHY Colorimetric Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHY Colorimetric Method, Cpk Or Isoenzymes

All 39
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K895870.
ELECSYS CK-MB STAT
K974421 · Boehringer Mannheim Corp. · Dec 1997
IMX(R) STAT CK-MB
K931172 · Abbott Laboratories · Jun 1993
COBAS READY CK REAGENT
K896240 · Roche Diagnostic Systems, Inc. · Feb 1990
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
K884550 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
IMX CKMB
K883013 · Abbott Laboratories · Aug 1988