Alinity i STAT High Sensitivity Troponin-I

K230994 · Abbott Laboratories Diagnostics Division · MMI · May 4, 2023 · Clinical Chemistry

Device Facts

• Record ID: K230994
• Device Name: Alinity i STAT High Sensitivity Troponin-I
• Applicant: Abbott Laboratories Diagnostics Division
• Product Code: MMI · Clinical Chemistry
• Decision Date: May 4, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The Alinity i STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnl) in human plasma (lithium heparin) on the Alinity i system. The Alinity i STAT High Sensitivity Troponin-I assay is to be used as an aid in the diagnosis of myocardial infarction (MI).

Device Story

The Alinity i STAT High Sensitivity Troponin-I is an automated, two-step chemiluminescent microparticle immunoassay (CMIA) for quantitative cTnI measurement. The device processes human lithium heparin plasma samples on the Alinity i system. The assay uses anti-troponin I antibody-coated paramagnetic microparticles and acridinium-labeled anti-troponin I conjugate. The system measures the resulting chemiluminescent reaction as relative light units (RLU), which are directly proportional to cTnI concentration. The device is used in clinical laboratory settings by trained personnel. The output provides quantitative cTnI levels, which clinicians use to aid in the diagnosis of myocardial infarction. This submission introduces automated and manual dilution procedures (1:30) to extend the reportable interval up to 60,000.0 ng/L.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to support the addition of the extended measuring interval (EMI) claim. No clinical data provided.

Technological Characteristics

In vitro diagnostic immunoassay; chemiluminescent microparticle immunoassay (CMIA) technology. Analyzed on Alinity i platform. Software-controlled automated processing. No changes to fundamental scientific technology.

Indications for Use

Indicated for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma on the Alinity i analyzer, intended for use as an aid in the diagnosis of myocardial infarction.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Alinity i STAT High Sensitivity Troponin-I (K202525)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K230994

B Applicant

Abbott Laboratories Diagnostics Division

C Proprietary and Established Names

Alinity i STAT High Sensitivity Troponin-I

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| MMI | Class II | 21 CFR 862.1215 - Creatine Phosphokinase/Creatine Kinase Or Isoenzymes Test System | CH - Clinical Chemistry |

## 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: K202525, Alinity i STAT High Sensitivity Troponin-I.
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).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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. The device modification is the addition of an extended measuring interval (EMI) claim for the device.

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.

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