Cleared Traditional

OCTEIA INTACT PTH (K941878) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941878 · I.D.S. · Chemistry device
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Sep 1994
Decision
142d
Days
Class 2
Risk

K941878 is an FDA 510(k) clearance for the OCTEIA INTACT PTH. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by I.D.S. (Tyne & Wear, GB). The FDA issued a Cleared decision on September 7, 1994 after a review of 142 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 I.D.S. devices

Submission Details

510(k) Number K941878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date September 07, 1994
Days to Decision 142 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
54d slower than avg
Panel avg: 88d · This submission: 142d
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 20
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K941878.
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
K011505 · Diagnostic Products Corp. · Jul 2001
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680 · Roche Diagnostics Corp. · Sep 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · Diagnostic Products Corp. · Jul 1999
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