Cleared Traditional

K871970 - DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2

K871970 is the FDA 510(k) clearance for DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 by Diagnostic Products Corp.. It is a Class 2 Chemistry device (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

Submission Details

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.

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 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
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · Diagnostic Products Corp. · Oct 1984