Cleared Traditional

K833768 - C. PTH RADIOIMMUNOASSAY KIT-CPTHK

K833768 is the FDA 510(k) clearance for C. PTH RADIOIMMUNOASSAY KIT-CPTHK by Sorin Biomedica, Fiat, USA, Inc.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K833768 · Sorin Biomedica, Fiat, USA, Inc. · Chemistry device
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Dec 1983
Decision
63d
Days
Class 2
Risk

K833768 is an FDA 510(k) clearance for the C. PTH RADIOIMMUNOASSAY KIT-CPTHK. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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 Sorin Biomedica, Fiat, USA, Inc. devices

Submission Details

510(k) Number K833768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1983
Decision Date December 29, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 - CEW Radioimmunoassay, Parathyroid Hormone

All 34
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K833768.
C-TERMINAL PTH RIA KIT
K853784 · Diagnostic Systems Laboratories, Inc. · Oct 1985
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · Diagnostic Products Corp. · Oct 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871 · Diagnostic Products Corp. · Oct 1984
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
K822944 · Travenol Laboratories, S.A. · Dec 1982
C-TERMINAL PTH RIA TEST KIT, DSL-1000
K813203 · Diagnostic Systems Laboratories, Inc. · Dec 1981
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K772249 · Kallestad Laboratories, Inc. · Dec 1977