Cleared Traditional

K211485 - STA- NeoPTimal (FDA 510(k) Clearance)

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

K211485 · Diagnostica Stago S.A.S · Hematology device
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Dec 2022
Decision
589d
Days
Class 2
Risk

K211485 is an FDA 510(k) clearance for the STA- NeoPTimal. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Diagnostica Stago S.A.S (Asniéres Sur Seine, FR). The FDA issued a Cleared decision on December 23, 2022 after a review of 589 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology 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 Hematology submissions.

View all Diagnostica Stago S.A.S devices

Submission Details

510(k) Number K211485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2021
Decision Date December 23, 2022
Days to Decision 589 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
476d slower than avg
Panel avg: 113d · This submission: 589d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 Hematology devices follow this clearance model.

Regulatory Consultant

Diagnostica Stago, Inc.
Anthony Dennis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 126
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