Cleared Traditional

K833275 - GMP CIQ ELISA TEST KIT

K833275 is an FDA 510(k) clearance for GMP CIQ ELISA TEST KIT, manufactured by Gamma Medical Products, Inc.. The device is a Class 2 Immunology device with product code DAK cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K833275 · Gamma Medical Products, Inc. · Immunology device
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Jun 1984
Decision
275d
Days
Class 2
Risk

K833275 is an FDA 510(k) clearance for the GMP CIQ ELISA TEST KIT. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by Gamma Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 275 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.

FDA 510(k) Submission Details - K833275

510(k) Number K833275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1983
Decision Date June 22, 1984
Days to Decision 275 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
170d slower than avg
Panel avg: 105d · This submission: 275d
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 25
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K833275.
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
K861499 · Biostar Medical Products, Inc. · Jun 1986
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
K851202 · Gilford · Apr 1985
CORDIA IC
K844294 · Cordis Corp. · Feb 1985
ORTHO* SERUM ELISA TEST SYSTEM
K833636 · Ortho Diagnostic Systems, Inc. · Jun 1984
SERUM COMPLEMENT ACTIVITY TEST-SCAT
K841541 · Collaborative Research, Inc. · Jun 1984
GAMMA CLQ
K823009 · Gamma Medical Products, Inc. · Nov 1982
K833275 · GMP CIQ ELISA TEST KIT
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