Cleared Traditional

K162227 - STA® - Liatest® D-Di

K162227 is an FDA 510(k) clearance for STA - Liatest D-Di, manufactured by Diagnostica-Stago. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K162227 · Diagnostica-Stago · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
124d
Days
Class 2
Risk

K162227 is an FDA 510(k) clearance for the STA® - Liatest® D-Di. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Diagnostica-Stago (Asnieres Sur Seine, FR). The FDA issued a Cleared decision on December 10, 2016 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostica-Stago devices

FDA 510(k) Submission Details - K162227

510(k) Number K162227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date December 10, 2016
Days to Decision 124 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
11d slower than avg
Panel avg: 113d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

DAP Device Classification - Class 2, Special Controls

Product Code DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Hematology devices follow this clearance model.

Regulatory Consultant

Donawa Lifescience Consulting
Carlo d'Alessandro

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.

Clinical Evidence

ClinicalTrials.gov
NCT01221805 Completed Observational Industry-sponsored

STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism

2040
Patients (actual)
18
Sites
Condition studied Deep Venous Thrombosis; Pulmonary Embolism; D-dimer
Eligibility All sexes
Principal investigator GILLES PERNOD, MD PhD
Sponsor Diagnostica Stago (industry)
Started 2011-11-01 → Primary completion 2016-03-01 → Completed 2016-04-01
Primary outcome
To demonstrate the ability of STA Liatest DDi combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism or deep venous thrombosis in a 3 month follow-up
Secondary outcome
1. To analyse results homogeneity (inter-centers) in the group "positive D-dimer result and negative diagnosis" (descriptive statistics only). 2. To determine prevalence of VTE in PTP high patients based on imaging results
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

All 50
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K162227.
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K141144 · Diagnostica-Stago · Sep 2014
VIDAS D-DIMER EXCLUSION II (DEX2)
K112818 · bioMerieux, Inc. · Jul 2012