Cleared Traditional

K922125 - STRATUS MYOGLOBIN FLUOROMETRIC ENZYME I...

K922125 is the FDA 510(k) clearance for STRATUS MYOGLOBIN FLUOROMETRIC ENZYME I... by Baxter Diagnostics, Inc.. It is a Class 2 Immunology device (product code DDR) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K922125 · Baxter Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
76d
Days
Class 2
Risk

K922125 is an FDA 510(k) clearance for the STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 76 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 Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K922125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1992
Decision Date July 21, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 104d · This submission: 76d
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 K922125.
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K962344 · Bayer Corp. · Aug 1996
ACCESS MYOGLOBIN REAGENTS
K951634 · Bio-Rad Laboratories, Inc. · Sep 1995
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K952360 · Princeton BioMeditech Corp. · Aug 1995
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL
K922387 · Baxter Diagnostics, Inc. · Jul 1992
OPUS MYOGLOBIN TEST SYSTEM
K915850 · Pb Diagnostic Systems, Inc. · Mar 1992
TURBIQUANT MYOGLOBIN
K905202 · Behring Diagnostics, Inc. · Dec 1990