Cleared Traditional

K921629 - N-TACT PTH SP KIT

K921629 is the FDA 510(k) clearance for N-TACT PTH SP KIT by Incstar Corp.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K921629 · Incstar Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
38d
Days
Class 2
Risk

K921629 is an FDA 510(k) clearance for the N-TACT(R) PTH SP KIT. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on May 14, 1992 after a review of 38 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 Incstar Corp. devices

Submission Details

510(k) Number K921629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date May 14, 1992
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 50
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K921629.
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
VENTREX COATED TUBE INTACT PTH
K913434 · Ventrex Laboratories, Inc. · Oct 1991
PTH-MM II 125I RADIOIMMUNOASSAY (RIA)
K901711 · Incstar Corp. · Jul 1990
DSL I-PTH (DSL #8000)
K896294 · Diagnostic Systems Laboratories, Inc. · Nov 1989