Cleared Traditional

K902154 - NA LATEX MYOGLOBIN TEST

K902154 is the FDA 510(k) clearance for NA LATEX MYOGLOBIN TEST by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code DDR) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K902154 · Behring Diagnostics, Inc. · Immunology device
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Jun 1990
Decision
17d
Days
Class 2
Risk

K902154 is an FDA 510(k) clearance for the NA LATEX MYOGLOBIN TEST. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on June 1, 1990 after a review of 17 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K902154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date June 01, 1990
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 104d · This submission: 17d
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 K902154.
OPUS MYOGLOBIN TEST SYSTEM
K915850 · Pb Diagnostic Systems, Inc. · Mar 1992
TURBIQUANT MYOGLOBIN
K905202 · Behring Diagnostics, Inc. · Dec 1990
TURBIQUANT MYOGLOBIN
K903687 · Behring Diagnostics, Inc. · Oct 1990
HEMAGGLUTINATION INHIBITION TEST
K772095 · Miles Laboratories, Inc. · Jan 1978
ANTISERA TO HUMAN FAB FRAGMENT
K771242 · Kent Laboratories, Inc. · Aug 1977