Cleared Traditional

K954418 - INTACT PARATHYROID HORMONE (PTH) IMMUNO...

K954418 is the FDA 510(k) clearance for INTACT PARATHYROID HORMONE (PTH) IMMUNO... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K954418 · Nichols Institute Diagnostics · Chemistry device
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Nov 1995
Decision
42d
Days
Class 2
Risk

K954418 is an FDA 510(k) clearance for the INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION). Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 42 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K954418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1995
Decision Date November 03, 1995
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K954418.
ACTIVE INTACT PTH
K973514 · Diagnostic Systems Laboratories, Inc. · Oct 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
K962598 · Nichols Institute Diagnostics · Dec 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
K962033 · Nichols Institute Diagnostics · Sep 1996
ACTIVE INTACT PTH ELISA
K952199 · Diagnostic Systems Laboratories, Inc. · Jul 1995
IMMUNLITE INTACT PTH
K934760 · Diagnostic Products Corp. · Dec 1993
COAT-A-COUNT INTACT PTH IRMA
K930008 · Diagnostic Products Corp. · Jun 1993