Cleared Traditional

K053533 - IMMULITE/IMMULITE 1000 TURBO INTACT PTH

K053533 is an FDA 510(k) clearance for IMMULITE/IMMULITE 1000 TURBO INTACT PTH, manufactured by Diagnostic Products Corporation. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K053533 · Diagnostic Products Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
46d
Days
Class 2
Risk

K053533 is an FDA 510(k) clearance for the IMMULITE/IMMULITE 1000 TURBO INTACT PTH. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Diagnostic Products Corporation (Los Angeles, US). The FDA issued a Cleared decision on February 3, 2006 after a review of 46 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 Diagnostic Products Corporation devices

FDA 510(k) Submission Details - K053533

510(k) Number K053533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2005
Decision Date February 03, 2006
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Chemistry devices follow this clearance model.

Regulatory Peers - CEW Radioimmunoassay, Parathyroid Hormone

All 75
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K053533.
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
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MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · Scantibodies Laboratory, Inc. · Feb 2006
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
K051888 · Scantibodies Laboratory, Inc. · Oct 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
K051810 · Scantibodies Laboratory, Inc. · Sep 2005
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
K051141 · Scantibodies Laboratory, Inc. · Jul 2005