Cleared Special

K013566 - IMMULITE INTACT PTH

K013566 is the FDA 510(k) clearance for IMMULITE INTACT PTH by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CEW) cleared through the Special 510(k) pathway after a 25-day FDA review.

K013566 · Diagnostic Products Corp. · Chemistry device
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Nov 2001
Decision
25d
Days
Class 2
Risk

K013566 is an FDA 510(k) clearance for the IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP.... 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 November 20, 2001 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K013566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2001
Decision Date November 20, 2001
Days to Decision 25 days
Submission Type Special
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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K013566.
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603 · Diagnostic Products Corp. · Aug 2002
AXSYM INTACT PTH, MODEL 2G06
K020945 · Diagnostic Systems Laboratories, Inc. · May 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
K013992 · Nichols Institute Diagnostics · Dec 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
K011505 · Diagnostic Products Corp. · Jul 2001
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680 · Roche Diagnostics Corp. · Sep 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · Diagnostic Products Corp. · Jul 1999