Cleared Traditional

K921949 - COTUBE PTH IRMA

K921949 is an FDA 510(k) clearance for COTUBE PTH IRMA, manufactured by Bio-Rad. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K921949 · Bio-Rad · Chemistry device
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Sep 1992
Decision
128d
Days
Class 2
Risk

K921949 is an FDA 510(k) clearance for the COTUBE PTH IRMA. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K921949

510(k) Number K921949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1992
Decision Date September 02, 1992
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEW Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K921949.
GAMMA-BCT INTACT PTH
K942369 · Immunodiagnostic Systems , Ltd. · Sep 1994
IMMUNLITE INTACT PTH
K934760 · Diagnostic Products Corp. · Dec 1993
COAT-A-COUNT INTACT PTH IRMA
K930008 · Diagnostic Products Corp. · Jun 1993
N-TACT(R) PTH SP KIT
K921629 · Incstar Corp. · May 1992
VENTREX COATED TUBE INTACT PTH
K913434 · Ventrex Laboratories, Inc. · Oct 1991
PTH-MM II 125I RADIOIMMUNOASSAY (RIA)
K901711 · Incstar Corp. · Jul 1990