Cleared Traditional

K871970 - DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2

K871970 is an FDA 510(k) clearance for DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2, manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K871970 · Diagnostic Products Corp. · Chemistry device
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Sep 1987
Decision
127d
Days
Class 2
Risk

K871970 is an FDA 510(k) clearance for the DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2. 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 September 25, 1987 after a review of 127 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K871970

510(k) Number K871970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1987
Decision Date September 25, 1987
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
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 K871970.
DSL I-PTH (DSL #8000)
K896294 · Diagnostic Systems Laboratories, Inc. · Nov 1989
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
K882560 · Ciba Corning Diagnostics Corp. · Oct 1988
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
K874299 · Incstar Corp. · Nov 1987
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY
K861797 · Nichols Institute Diagnostics · Jul 1986
C-TERMINAL PTH RIA KIT
K853784 · Diagnostic Systems Laboratories, Inc. · Oct 1985
PTH-RIA
K844735 · Syncor Intl. Corp. · Apr 1985