I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE

K112430 · Abbott Pont of Care, Inc. · KHP · Dec 20, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112430
• Device Name: I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
• Applicant: Abbott Pont of Care, Inc.
• Product Code: KHP · Clinical Chemistry
• Decision Date: Dec 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1450
• Device Class: Class 1

Indications for Use

The i-STAT Lactate Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status. (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemia. The i-STAT Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.

Device Story

i-STAT Lactate Test is an in vitro diagnostic component of the i-STAT System; measures lactate levels in arterial, venous, or capillary whole blood. Used by healthcare professionals in clinical settings to assess tissue hypoperfusion, sepsis, trauma, and surgical recovery. Device provides quantitative lactate data to assist clinicians in diagnosing lactic acidosis and hyperlactatemia; monitoring patient status during hypoxia or physical exertion. System utilizes electrochemical biosensor technology within a cartridge format; results displayed on i-STAT handheld analyzer. Enables rapid point-of-care decision-making regarding patient metabolic status.

Clinical Evidence

No new clinical data provided. All analytical and clinical performance characteristics, including precision, linearity, detection limits, specificity, and method comparison, were established in the original submission (k982071).

Technological Characteristics

Quantitative electrochemical biosensor; lactate oxidase enzyme immobilization; amperometric sensing principle. Form factor: i-STAT cartridge for use with i-STAT analyzer. No changes to materials or technology from predicate.

Indications for Use

Indicated for patients requiring diagnosis/treatment of lactic acidosis, monitoring of tissue hypoxia or strenuous physical exertion, and diagnosis of hyperlactatemia. Used for in vitro measurement of lactate in arterial, venous, or capillary whole blood.

Regulatory Classification

Identification

A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Predicate Devices

• iSTAT Lactate test (k982071)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k112430

B. Purpose for Submission:
Minor labeling modification to a previously cleared device (k982071)

C. Measurand:
Lactic acid

D. Type of Test:
Quantitative, electrochemical biosensor (lactate oxidase)

E. Applicant:
Abbott Point of Care Inc.

F. Proprietary and Established Names:
i-STAT Lactate Test

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1450, Lactic acid test system
2. Classification:
Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(9)
3. Product code:
KHP – Acid, Lactic, Enzyme Method
4. Panel:
Clinical Chemistry (75)

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H. Intended Use:

1. Intended use(s):
See indications for use below

2. Indication(s) for use:
The Lactate Acid Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
i-STAT analyzer

I. Device Description:
Refer to k982071

J. Substantial Equivalence Information:

1. Predicate device name(s):
iSTAT Lactate test

2. Predicate 510(k) number(s):
k982071

3. Comparison with predicate:
No changes were made to the device since k982071. Only minor labeling changes were made to the labeling in this submission.

K. Standard/Guidance Document Referenced (if applicable):
No standards were referenced in the submission

L. Test Principle:
Lactate is measured amperometrically by conversion of lactate to pyruvate and hydrogen peroxide by lactate oxidase immobilized on a biosensor.

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No changes have been made to the device technology in this submission. Refer to k982071

## M. Performance Characteristics (if/when applicable):

1. **Analytical performance:**
a. **Precision/Reproducibility**: Established in the original submission (k982071)
b. **Linearity/assay reportable range**: Established in the original submission (k982071)
c. **Traceability, Stability, Expected values (controls, calibrators, or methods)**: Established in the original submission (k982071)
d. **Detection limit**: Established in the original submission (k982071)
e. **Analytical specificity**: Established in the original submission (k982071)
f. **Assay cut-off**: Not Applicable

2. **Comparison studies:**
a. **Method comparison with predicate device**: Established in the original submission (k982071)
b. **Matrix comparison**: Established in the original submission (k982071)

3. **Clinical studies:**
a. **Clinical Sensitivity**: Not Applicable
b. **Clinical specificity**: Not Applicable

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c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Established in the original submission (k982071)

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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