Cleared Traditional

K821412 - C-REACTIVE PROTEIN CONTROL

K821412 is the FDA 510(k) clearance for C-REACTIVE PROTEIN CONTROL by Syva Co.. It is a Class 2 Chemistry device (product code DCK) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K821412 · Syva Co. · Chemistry device
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Jul 1982
Decision
71d
Days
Class 2
Risk

K821412 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN CONTROL. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry 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 Syva Co. devices

Submission Details

510(k) Number K821412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1982
Decision Date July 22, 1982
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 81
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K821412.
PRISMA C-REACTIVE PROTEIN ASSAY
K823416 · Syva Co. · Dec 1982
PRISMA-C-REACTIVE PROTEIN CALIBRATORS
K823417 · Syva Co. · Dec 1982
EMIT C-REACTIVE PROTEIN AUTOCAROUSEL
K822067 · Syva Co. · Jul 1982
QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
K821984 · Kallestad Laboratories, Inc. · Jul 1982
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
K811617 · Kallestad Laboratories, Inc. · Jun 1981
AGGLUTINOTEST-C-REACTIVE PROTEIN
K791461 · Volu Sol Medical Industries · Dec 1979