Cleared Traditional

K851842 - SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

K851842 is the FDA 510(k) clearance for SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN by Atlantic Antibodies. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K851842 · Atlantic Antibodies · Immunology device
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Jun 1985
Decision
40d
Days
Class 2
Risk

K851842 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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 Atlantic Antibodies devices

Submission Details

510(k) Number K851842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date June 05, 1985
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 104d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 83
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K851842.
DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR
K860549 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1986
DU PONT C-REACTIVE PROTEIN (CRP) ASSAY
K860550 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1986
TDX C-REACTIVE PROTEIN
K854542 · Abbott Laboratories · Jan 1986
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
K831958 · Kent Laboratories, Inc. · Jul 1983
PRISMA C-REACTIVE PROTEIN CONTROLS
K823415 · Syva Co. · Dec 1982
PRISMA C-REACTIVE PROTEIN ASSAY
K823416 · Syva Co. · Dec 1982