Cleared Traditional

K022660 - BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117

K022660 is an FDA 510(k) clearance for BIOCHECK MYOGLOBIN ELISA, manufactured by Biocheck, Inc.. The device is a Class 2 Chemistry device with product code DRR cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K022660 · Biocheck, Inc. · Chemistry device
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Dec 2002
Decision
132d
Days
Class 2
Risk

K022660 is an FDA 510(k) clearance for the BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117. Classified as Amplifier And Signal Conditioner, Biopotential (product code DRR), Class II - Special Controls.

Submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on December 19, 2002 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 870.2050 - 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 - K022660

510(k) Number K022660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date December 19, 2002
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRR Device Classification - Class 2, Special Controls

Product Code DRR Amplifier And Signal Conditioner, Biopotential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2050
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 - DRR Amplifier And Signal Conditioner, Biopotential

All 13
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