Cleared Traditional

K833636 - ORTHO* SERUM ELISA TEST SYSTEM

K833636 is an FDA 510(k) clearance for ORTHO* SERUM ELISA TEST SYSTEM, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K833636

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
135d slower than avg
Panel avg: 105d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAK Device Classification - Class 2, Special Controls

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 16
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