← Product Code [KFF](/productcode/KFF) · K260214

# STA® - Liquid Anti-Xa (K260214)

_Diagnostica Stago, Inc. · KFF · Sep 24, 2026 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K260214

## Device Facts

- **Applicant:** Diagnostica Stago, Inc.
- **Product Code:** [KFF](/productcode/KFF.md)
- **Decision Date:** Sep 24, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.7525
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The STA – Liquid Anti-Xa is an in vitro diagnostic application for the quantitative determination of heparin (unfractionated heparin and low molecular weight heparin) in human citrated plasma using the STA-R series of analyzers.

## Device Story

STA – Liquid Anti-Xa assay; in vitro diagnostic reagent for quantitative heparin measurement in human citrated plasma. Modification: addition of STA R Max 3 (K212183) analyzer compatibility. Device operates on STA-R series analyzers; measures anti-Xa activity to monitor heparin therapy. Used in clinical laboratory settings by trained technicians. Output: quantitative heparin concentration. Modification verified via design control activities and risk analysis to ensure fundamental scientific technology remains unchanged.

## Clinical Evidence

Bench testing only. Verification and validation activities were performed to confirm performance of the STA Liquid Anti-Xa assay on the STA R Max 3 analyzer, demonstrating that the modification did not impact the device's fundamental scientific technology or intended use.

## Technological Characteristics

In vitro diagnostic reagent for heparin assay. Compatible with STA-R series analyzers, specifically the STA R Max 3. Fundamental scientific technology remains unchanged from the previously cleared version.

## Regulatory Identification

A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

## Predicate Devices

- STA® Liquid Anti-Xa ([K111822](/device/K111822.md))

## Submission Summary (Full Text)

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# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

# I Background Information:

A 510(k) Number

K260214

B Applicant

Diagnostica Stago

C Proprietary and Established Names

STA – Liquid Anti-Xa

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  KFF | Class II | 864.7525 Heparin Assay | Hematology  |

# II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the addition of the STA R Max 3 (K212183) analyzer as a compatible analyzer for use with the STA Liquid Anti-Xa assay.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

K260214 - Page 2 of 2

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**Source:** [https://fda-staging.innolitics.com/device/K260214](https://fda-staging.innolitics.com/device/K260214)

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