Cleared Traditional

K962033 - CHEMILUMINESCENCE INTRA-OPERATIVE INTAC...

K962033 is the FDA 510(k) clearance for CHEMILUMINESCENCE INTRA-OPERATIVE INTAC... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K962033 · Nichols Institute Diagnostics · Chemistry device
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Sep 1996
Decision
126d
Days
Class 2
Risk

K962033 is an FDA 510(k) clearance for the CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT. 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 September 27, 1996 after a review of 126 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K962033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1996
Decision Date September 27, 1996
Days to Decision 126 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
38d slower than avg
Panel avg: 88d · This submission: 126d
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 K962033.
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K962598 · Nichols Institute Diagnostics · Dec 1996
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
K954418 · Nichols Institute Diagnostics · Nov 1995
ACTIVE INTACT PTH ELISA
K952199 · Diagnostic Systems Laboratories, Inc. · Jul 1995
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K934760 · Diagnostic Products Corp. · Dec 1993