Cleared Traditional

K221197 - VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221197 · Ortho-Clinical Diagnostics · Chemistry device
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Sep 2023
Decision
498d
Days
Class 2
Risk

K221197 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products Intact PTH II Reagent Pack. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on September 5, 2023 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K221197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date September 05, 2023
Days to Decision 498 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
410d slower than avg
Panel avg: 88d · This submission: 498d
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.