Cleared Traditional

K004038 - TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA)...

K004038 is an FDA 510(k) clearance for TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA)..., manufactured by Scantibodies Laboratory, Inc.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K004038 · Scantibodies Laboratory, Inc. · Chemistry device
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Apr 2001
Decision
123d
Days
Class 2
Risk

K004038 is an FDA 510(k) clearance for the TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on April 30, 2001 after a review of 123 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 Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K004038

510(k) Number K004038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2000
Decision Date April 30, 2001
Days to Decision 123 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
35d slower than avg
Panel avg: 88d · This submission: 123d
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 72
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K004038.
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
K013992 · Nichols Institute Diagnostics · Dec 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
K013566 · Diagnostic Products Corp. · Nov 2001
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
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
K001411 · Scantibodies Laboratory, Inc. · Aug 2000
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680 · Roche Diagnostics Corp. · Sep 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · Diagnostic Products Corp. · Jul 1999