Cleared Traditional

K904125 - UC IMU A

K904125 is an FDA 510(k) clearance for UC IMU A, manufactured by Eucardio Laboratory, Inc.. The device is a Class 2 Immunology device with product code DER cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K904125 · Eucardio Laboratory, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
18d
Days
Class 2
Risk

K904125 is an FDA 510(k) clearance for the UC IMU A. Classified as Alpha-1-lipoprotein, Antigen, Antiserum, Control (product code DER), Class II - Special Controls.

Submitted by Eucardio Laboratory, Inc. (San Diego, US). The FDA issued a Cleared decision on September 24, 1990 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5580 - 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 Eucardio Laboratory, Inc. devices

FDA 510(k) Submission Details - K904125

510(k) Number K904125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date September 24, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 105d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DER Device Classification - Class 2, Special Controls

Product Code DER Alpha-1-lipoprotein, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5580
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 - DER Alpha-1-lipoprotein, Antigen, Antiserum, Control

All 12
Devices cleared under the same product code (DER) and FDA review panel - the closest regulatory comparables to K904125.
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
K964294 · Crestat Diagnostics, Inc. · Aug 1997
N-ASSAY TIA APO B TEST KIT
K964296 · Crestat Diagnostics, Inc. · Aug 1997
ROCHE APOLIPOPROTEIN STANDARD
K910553 · Roche Diagnostic Systems, Inc. · May 1991
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
K840830 · Ventrex Laboratories, Inc. · May 1984
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
K802610 · Hyland Therapeutic Div., Travenol Laboratories · Jan 1981