Cleared Traditional

BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (K022660) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 23
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