Cleared Traditional

K101921 - VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT

K101921 is an FDA 510(k) clearance for VITROS IMMUNODIAGNOSTICS PRODUCTS INTAC..., manufactured by Ortho-Clinical Diagnostics. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K101921 · Ortho-Clinical Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2010
Decision
105d
Days
Class 2
Risk

K101921 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGN.... Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 105 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 Ortho-Clinical Diagnostics devices

FDA 510(k) Submission Details - K101921

510(k) Number K101921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2010
Decision Date October 22, 2010
Days to Decision 105 days
Submission Type Traditional
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
17d slower than avg
Panel avg: 88d · This submission: 105d
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 74
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K101921.
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K132515 · DiaSorin, Inc. · Nov 2013
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
K121981 · Siemens Healthcare Diagnostics · Mar 2013
IDS-ISYS INTACT PTH
K103325 · Immunodiagnostic Systems , Ltd. · Feb 2012
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · Roche Diagnostics Corp. · Jul 2007
ST AIA-PACK INTACT PTH ASSAY
K063605 · Tosoh Bioscience, Inc. · Jun 2007
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
K063232 · Biokit, S.A. · Jun 2007