Cleared Traditional

K930008 - COAT-A-COUNT INTACT PTH IRMA

K930008 is the FDA 510(k) clearance for COAT-A-COUNT INTACT PTH IRMA by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K930008 · Diagnostic Products Corp. · Chemistry device
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Jun 1993
Decision
162d
Days
Class 2
Risk

K930008 is an FDA 510(k) clearance for the COAT-A-COUNT INTACT PTH IRMA. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 15, 1993 after a review of 162 days - an extended review 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: 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K930008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1993
Decision Date June 15, 1993
Days to Decision 162 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
74d slower than avg
Panel avg: 88d · This submission: 162d
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 49
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K930008.
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
COTUBE PTH IRMA
K921949 · Bio-Rad · Sep 1992
N-TACT(R) PTH SP KIT
K921629 · Incstar Corp. · May 1992
VENTREX COATED TUBE INTACT PTH
K913434 · Ventrex Laboratories, Inc. · Oct 1991