Cleared Traditional

K833636 - ORTHO* SERUM ELISA TEST SYSTEM

K833636 is the FDA 510(k) clearance for ORTHO* SERUM ELISA TEST SYSTEM by Ortho Diagnostic Systems, Inc.. It is a Class 2 Immunology device (product code DAK) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K833636 · Ortho Diagnostic Systems, Inc. · Immunology device
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Jun 1984
Decision
240d
Days
Class 2
Risk

K833636 is an FDA 510(k) clearance for the ORTHO* SERUM ELISA TEST SYSTEM. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on June 13, 1984 after a review of 240 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K833636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date June 13, 1984
Days to Decision 240 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
136d slower than avg
Panel avg: 104d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAK Complement C1q, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DAK Complement C1q, Antigen, Antiserum, Control

All 13
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K833636.
C1 RID KIT
K914388 · The Binding Site, Ltd. · Oct 1991
IC MICROASSAY
K864312 · Diamedix Corp. · Jan 1987
CORDIA IC
K844294 · Cordis Corp. · Feb 1985
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949 · Ortho Diagnostic Systems, Inc. · Aug 1982
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
K821806 · Ortho Diagnostic Systems, Inc. · Jun 1982
ELECTRO-IMMUNO-QUANTITATION (EIQ)
K792472 · Icl Scientific · Dec 1979