Cleared Special

K022603 - IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER

K022603 is an FDA 510(k) clearance for IMMULITE 1000 AUTOMATED IMMUNOASSAY ANA..., manufactured by Diagnostic Products Corp.. The device is a Class 2 Toxicology device with product code CEW cleared through the Special 510(k) pathway after a 15-day FDA review.

K022603 · Diagnostic Products Corp. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
15d
Days
Class 2
Risk

K022603 is an FDA 510(k) clearance for the IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER. 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 August 21, 2002 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1545 - the FDA toxicology device 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.

FDA 510(k) Submission Details - K022603

510(k) Number K022603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2002
Decision Date August 21, 2002
Days to Decision 15 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

CEW Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - CEW Radioimmunoassay, Parathyroid Hormone

All 82
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K022603.
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
K033302 · Nichols Institute Diagnostics · Jan 2004
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
K031534 · Scantibodies Laboratory, Inc. · Jul 2003
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
K022472 · Nichols Institute Diagnostics · Oct 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, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
K013566 · Diagnostic Products Corp. · Nov 2001
K022603 · IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
Download PDF FDA Summary Diagnostic Products C…