Cleared Traditional

K951634 - ACCESS MYOGLOBIN REAGENTS

K951634 is the FDA 510(k) clearance for ACCESS MYOGLOBIN REAGENTS by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code DDR) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K951634 · Bio-Rad Laboratories, Inc. · Chemistry device
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Sep 1995
Decision
173d
Days
Class 2
Risk

K951634 is an FDA 510(k) clearance for the ACCESS MYOGLOBIN REAGENTS. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 173 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5680 - 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K951634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1995
Decision Date September 27, 1995
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 88d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 - DDR Myoglobin, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K951634.
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · Dade Behring, Inc. · Apr 1998
TINAQUANT MYOGLOBIN ASSAY
K972513 · Boehringer Mannheim Corp. · Jul 1997
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K962344 · Bayer Corp. · Aug 1996
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K952360 · Princeton BioMeditech Corp. · Aug 1995
STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY
K922125 · Baxter Diagnostics, Inc. · Jul 1992
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL
K922387 · Baxter Diagnostics, Inc. · Jul 1992