Cleared Traditional

K041619 - BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116

K041619 is an FDA 510(k) clearance for BIO CHECK WHOLE BLOOD/PLASMA/SERMON MOD..., manufactured by Biocheck, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K041619 · Biocheck, Inc. · Chemistry device
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Dec 2004
Decision
185d
Days
Class 2
Risk

K041619 is an FDA 510(k) clearance for the BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 185 days - an extended review 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: 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 Biocheck, Inc. devices

FDA 510(k) Submission Details - K041619

510(k) Number K041619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date December 17, 2004
Days to Decision 185 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
97d slower than avg
Panel avg: 88d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMI Device Classification - Class 2, Special Controls

Product Code MMI Immunoassay Method, Troponin Subunit
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 - MMI Immunoassay Method, Troponin Subunit

All 79
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K041619.
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
K053020 · Bayer Healthcare, LLC · Dec 2005
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
K052503 · Bayer Healthcare, LLC · Dec 2005
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
K051752 · Roche Diagnostics · Jul 2005
INSTANT-VIEW TROPONIN I TEST
K042227 · Alfa Scientific Designs, Inc. · Nov 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · Abbott Laboratories · Sep 2004
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
K041192 · Fisher Diagnostics · Aug 2004