Cleared Traditional

K942369 - GAMMA-BCT INTACT PTH

K942369 is the FDA 510(k) clearance for GAMMA-BCT INTACT PTH by Immunodiagnostic Systems , Ltd.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K942369 · Immunodiagnostic Systems , Ltd. · Chemistry device
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Sep 1994
Decision
125d
Days
Class 2
Risk

K942369 is an FDA 510(k) clearance for the GAMMA-BCT INTACT PTH. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Immunodiagnostic Systems , Ltd. (Tyne And Wear, GB). The FDA issued a Cleared decision on September 20, 1994 after a review of 125 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.

View all Immunodiagnostic Systems , Ltd. devices

Submission Details

510(k) Number K942369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1994
Decision Date September 20, 1994
Days to Decision 125 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 88d · This submission: 125d
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 51
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K942369.
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
K962033 · Nichols Institute Diagnostics · Sep 1996
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
K954418 · Nichols Institute Diagnostics · Nov 1995
ACTIVE INTACT PTH ELISA
K952199 · Diagnostic Systems Laboratories, Inc. · Jul 1995
IMMUNLITE INTACT PTH
K934760 · Diagnostic Products Corp. · Dec 1993
COAT-A-COUNT INTACT PTH IRMA
K930008 · Diagnostic Products Corp. · Jun 1993
COTUBE PTH IRMA
K921949 · Bio-Rad · Sep 1992