Cleared Traditional

K915850 - OPUS MYOGLOBIN TEST SYSTEM

K915850 is the FDA 510(k) clearance for OPUS MYOGLOBIN TEST SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 2 Immunology device (product code DDR) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K915850 · Pb Diagnostic Systems, Inc. · Immunology device
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Mar 1992
Decision
82d
Days
Class 2
Risk

K915850 is an FDA 510(k) clearance for the OPUS MYOGLOBIN TEST SYSTEM. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on March 17, 1992 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5680 - the FDA immunology device 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K915850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1991
Decision Date March 17, 1992
Days to Decision 82 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 104d · This submission: 82d
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 Immunology devices follow this clearance model.

Regulatory Peers - DDR Myoglobin, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K915850.
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
TURBIQUANT MYOGLOBIN
K905202 · Behring Diagnostics, Inc. · Dec 1990
TURBIQUANT MYOGLOBIN
K903687 · Behring Diagnostics, Inc. · Oct 1990
NA LATEX MYOGLOBIN TEST
K902154 · Behring Diagnostics, Inc. · Jun 1990