Cleared Traditional

K772249 - COMPLEMENT C3 NEPHELOMETRIC ASSAY

K772249 is the FDA 510(k) clearance for COMPLEMENT C3 NEPHELOMETRIC ASSAY by Kallestad Laboratories, Inc.. It is a Class 2 Immunology device (product code CEW) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K772249 · Kallestad Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1977
Decision
13d
Days
Class 2
Risk

K772249 is an FDA 510(k) clearance for the COMPLEMENT C3 NEPHELOMETRIC ASSAY. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1977 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1545 - 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K772249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1977
Decision Date December 22, 1977
Days to Decision 13 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
91d faster than avg
Panel avg: 104d · This submission: 13d
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 Immunology devices follow this clearance model.

Regulatory Peers - CEW Radioimmunoassay, Parathyroid Hormone

All 50
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K772249.
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
HORMONE KIT, PARATHYROID
K782010 · Nichols Institute Diagnostics · Jan 1979
PTH RIA
K771783 · Nichols Institute Diagnostics · Oct 1977