Cleared Traditional

K843871 - PARATHYROID HORMONE C-TERMINAL RIA KIT

K843871 is the FDA 510(k) clearance for PARATHYROID HORMONE C-TERMINAL RIA KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K843871 · Diagnostic Products Corp. · Chemistry device
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Oct 1984
Decision
28d
Days
Class 2
Risk

K843871 is an FDA 510(k) clearance for the PARATHYROID HORMONE C-TERMINAL RIA KIT. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K843871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date October 30, 1984
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 K843871.
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
C-TERMINAL/MID-MOLECULE PARATHYROID -
K843685 · Nichols Institute Diagnostics · Oct 1984
PARATHYROID HORMONE ANALYSIS PRODUCT
K840379 · Nichols Institute Diagnostics · Apr 1984
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
K822944 · Travenol Laboratories, S.A. · Dec 1982