Cleared Traditional

K802404 - ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE

K802404 is the FDA 510(k) clearance for ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE by Ortho Diagnostics, Inc.. It is a Class 2 Immunology device (product code DCF) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K802404 · Ortho Diagnostics, Inc. · Immunology device
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Oct 1980
Decision
17d
Days
Class 2
Risk

K802404 is an FDA 510(k) clearance for the ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Ortho Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5040 - 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 Ortho Diagnostics, Inc. devices

Submission Details

510(k) Number K802404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1980
Decision Date October 23, 1980
Days to Decision 17 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: 104d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 29
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K802404.
ALBUMIN IN SERUM
K873862 · Unipath , Ltd. · Oct 1987
ALBUMIN IN URINE
K873861 · Unipath , Ltd. · Oct 1987
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM
K812496 · Dako Corp. · Sep 1981
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
K780913 · Beckman Instruments, Inc. · Jun 1978
QUAN. COLOR. DETER. OF SERUM ALBUMIN
K771771 · Stanbio Laboratory · Oct 1977
LOW LEVEL HUMAN ALBUMIN TEST KITS
K761225 · Intl. Diagnostic Technology · Apr 1977