Cleared Traditional

K202852 - DiviTum TKa (FDA 510(k) Clearance)

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

K202852 · Biovica International AB · Immunology device
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Jul 2022
Decision
669d
Days
Class 2
Risk

K202852 is an FDA 510(k) clearance for the DiviTum TKa. Classified as Thymidine Kinase Activity (product code QTE), Class II - Special Controls.

Submitted by Biovica International AB (Uppsala, SE). The FDA issued a Cleared decision on July 29, 2022 after a review of 669 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device 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 Immunology submissions.

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Submission Details

510(k) Number K202852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date July 29, 2022
Days to Decision 669 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
565d slower than avg
Panel avg: 104d · This submission: 669d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QTE Thymidine Kinase Activity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
Definition In Vitro Test To Measure Thymidine Kinase Activity (tka) To Aid In Monitoring Disease Progression Of Breast Cancer Patients.
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 Immunology devices follow this clearance model.