Cleared Traditional

OLYMPUS CK-MB REAGENT (K070835) - FDA 510(k) Clearance

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

K070835 · Olympus Life & Material Science Europa GmbH (Irish · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
69d
Days
Class 2
Risk

K070835 is an FDA 510(k) clearance for the OLYMPUS CK-MB REAGENT. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Olympus Life & Material Science Europa GmbH (Irish (O'Callaghans Mills, Co. Clare, IE). The FDA issued a Cleared decision on June 4, 2007 after a review of 69 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 Olympus Life & Material Science Europa GmbH (Irish devices

Submission Details

510(k) Number K070835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2007
Decision Date June 04, 2007
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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 K070835.
SPIFE CK KIT, MODEL 3332, 3333
K022757 · Helena Laboratories · Oct 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · Roche Diagnostics Corp. · Aug 2002
ELECSYS CK-MB STAT
K974421 · Boehringer Mannheim Corp. · Dec 1997
IMX(R) STAT CK-MB
K931172 · Abbott Laboratories · Jun 1993
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
K922700 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
COBAS READY CK REAGENT
K896240 · Roche Diagnostic Systems, Inc. · Feb 1990