Cleared Traditional

LOW LEVEL HUMAN ALBUMIN TEST KITS (K761225) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K761225 · Intl. Diagnostic Technology · Immunology device
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Apr 1977
Decision
120d
Days
Class 2
Risk

K761225 is an FDA 510(k) clearance for the LOW LEVEL HUMAN ALBUMIN TEST KITS. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on April 7, 1977 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Diagnostic Technology devices

Submission Details

510(k) Number K761225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1976
Decision Date April 07, 1977
Days to Decision 120 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 104d · This submission: 120d
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 36
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K761225.
COBAS 8000 MODULAR SERIES ANALYZER
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SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
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DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE
K061990 · Dade Behring, Inc. · Sep 2006
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
K033525 · Dade Behring, Inc. · Jan 2004
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
K964695 · Beckman Instruments, Inc. · Apr 1997
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
K961824 · Roche Diagnostic Systems, Inc. · Jul 1996