For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.

Device Description

CARESIDE ALT cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure ALT activity in anti-coagulated whole blood, plasma, or serum specimens. The CARESIDE® ALT cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of sample to a dry film to initiate the measurement of ALT activity. The patented film cartridge contains all reagents necessary to measure ALT activity.

Each CARESIDE ALT cartridge consists of an ALT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge sample well, closes the lid and inserts the cartridge into the CARESIDE Analyzer.

Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample well into the cartridge channels and chambers. Approximately 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.

The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer uniformly distributes the specimen. As the specimen passes through the spreading and substrate layer, ALT in the specimen catalyzes the reaction of L-aspartate and a-ketotglutaric acid to form pyruvic acid and L-glutamic acid (see Test Reaction Sequence). The pyruvic acid is converted to acetyl phosphoric acid, CO2 and hydrogen peroxide in the reaction layer. Peroxidase in the reaction layer then catalyzes the oxidation of a diaryliminidazole leuco dye by hydrogen peroxide to form a green dye. The rate of change of intensity of the color as measured by the amount of reflected light at 655 directly relates to the amount of ALT activity in the specimen.

AI/ML Overview

The provided document describes the CARESIDE® ALT test system, an in vitro diagnostic device for quantitatively measuring Alanine Aminotransferase (ALT) activity. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria. Therefore, the document does not contain an "acceptance criteria" table in the traditional sense of a new clinical trial setting with predefined endpoints that need to be met for device approval. Instead, it presents a comparison of the CARESIDE ALT's performance characteristics against those of the predicate device (Vitros ALT DT Slides) to show "substantial equivalence."

Here's the information extracted and organized based on your request, focusing on the comparative performance data provided:

1. Table of Acceptance Criteria (Comparative Performance) and Reported Device Performance

As this is a 510(k) submission showing substantial equivalence, there are no explicitly stated "acceptance criteria" for a new device's clinical performance. Instead, the performance of the CARESIDE ALT is compared to the predicate device and the new device's performance is presented. The implicit "acceptance criterion" is that the CARESIDE ALT performs "as well as or better than" the predicate device.

Performance Characteristic	CARESIDE® ALT Reported Performance	Predicate Device (Vitros ALT DT Slides) Reported Performance	Implied "Acceptance" (Substantial Equivalence)
Detection Limit	15 U/L	3 U/L	Note: Predicate is lower. This may be acceptable if clinical utility is not impacted at relevant physiological ranges.
Reportable Range	15 - 1000 U/L	3 - 950 U/L	Note: CARESIDE ALT has a higher upper limit, which may be considered favorable.
Accuracy (Mean Recovery)	106%	Not available	CARESIDE ALT reports a specific value.
Precision (Total CV)	4.5% at 22 U/L	9.5% at 40 U/L	CARESIDE ALT demonstrates better precision (lower CV) at a lower ALT concentration.
Method Comparison (Correlation to BM/Hitachi 902)	CARESIDE® = 0.98 (BM/Hitachi 902) + 4.75 U/L, r = 1.00	Not available	CARESIDE ALT shows excellent correlation with an established method.
Linearity	Slope and correlation coefficient within acceptable limits	Not available	CARESIDE ALT demonstrates linearity.
Interference	No significant interference observed at tested concentrations of:	High gamma globulin	CARESIDE ALT shows no significant interference for common interferents tested, and overcomes a known interference of the predicate device (high gamma globulin).
	- Ascorbic Acid, 10 mg/dL
	- Bilirubin, 20 mg/dL
	- Triglycerides 3000 mg/dL
	- Gamma globulin 4200 mg/dL

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the "test set" (i.e., the number of patient samples or specimens used for the accuracy, precision, linearity, method comparison, and interference studies). It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (experts, qualifications, etc.) is typically associated with studies involving human interpretation (e.g., image analysis, diagnoses). The CARESIDE ALT is an in vitro diagnostic device for quantitative chemical measurement. Its "ground truth" would be established by reference methods or laboratory-grade analyzers. Therefore, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant to studies where human readers interpret and classify data, and discrepancies need resolution. This is not applicable to a quantitative in vitro diagnostic device where measurements are compared to reference methods or statistical thresholds for performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The CARESIDE ALT is an in vitro diagnostic device for measuring a chemical analyte, not an AI-powered diagnostic system requiring human interpretation or assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance data presented (accuracy, precision, method comparison, linearity, interference) describes the standalone performance of the CARESIDE ALT device, as it is an automated quantitative measurement system that does not involve human interpretation for its primary function.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics appears to be established using:

Reference Method Comparisons: For accuracy and method comparison, the CARESIDE ALT measurements were compared against results from other established analytical methods, such as the "BM/Hitachi 902" analyzer and a "NADH/NAD coupled reduction of pyruvate by lactate dehydrogenase" reference method. The predicate device also refers to the "IFCC, 1978" method.
Known Concentrations/Spiked Samples: For linearity, "linearity by mixing" was employed, suggesting known concentrations were used. Interference studies involved adding known concentrations of potential interfering substances.
Statistical Analysis: Precision is determined through statistical analysis of replicate measurements.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical assay, and its development would typically involve optimization and validation runs rather than a distinct "training set" in the computational sense. The document focuses on demonstrating the final product's performance.

9. How the Ground Truth for the Training Set Was Established

As no "training set" in the AI/ML sense is mentioned, this question is not applicable to the information provided. The development of a chemical assay involves extensive R&D, optimization using laboratory standards, and clinical validation using patient samples, but these are not typically categorized as "training sets" with associated "ground truth establishment" in the way an AI algorithm would be described.

Summary

{0}------------------------------------------------

(020487)

CARESIDE ALT Premarket Notificatio April 30, 2002

510(K) SUMMARY: CARESIDE® ALT SAFETY AND IV. EFFECTIVENESS

I. Applicant Information

Applicant Name A.
Applicant/Manufacturer B. Address
Telephone Number C.
Contact Person D.
FAX Number E.
e-Mail Address F.
G. Date 510(k) Summary prepared

II. Device Information

A. Device Name (Trade)
Device Name B. (Classification)

C. Device Classification

CARESIDE, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Renate A. MacLaren, Ph.D. 310-670-6986 rmaclaren@CARESIDE.com April 30, 2002

CARESIDE® ALT ALT test system

Clinical chemistry panel ALT test system Regulation Number: 21 CFR 862.1030 Regulatory Class I Classification Number: to be assigned None applicable

Special controls and D. performance standards

III. Substantial Equivalence Claim

General equivalency claim A.
The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays. ALT in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market.

B. Specific equivalency claim

The CARESIDE ALT test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of ALT on the Vitros DT 60 II.

Name of Predicate Device: Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros ALT DT Slides for Johnson and Johnson's Vitros DT 60 (formerly Eastman Kodak's DT 60 II).

{1}------------------------------------------------

Predicate Device 510K number:	K912844/A
Product Code:	75CKA

IV. Device Description

A. Explanation of Device Function

Test Reaction Sequence:

L-alanine + a-ketoglutaric acid - 415-

Pyruvic acid + L-glutamic acid

Pyruvic acid + O2 + phosphoric acid ->

H2O2 + CO2 + acetyl phosphoric acid

Diarylimidazole leuco dye + H2O2 - - Green dye + H2O

As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time

{2}------------------------------------------------

period. The analyzer uses the reflectance measurements and the lotspecific standard curve to calculate ALT activity.

B. Test Summary
Alanine aminotransferase, formerly known as serum glutamate pyruvate transaminase (SGPT), is an enzyme involved in the metabolism of amino acids. It is found in numerous organs and tissues with the highest levels in the kidneys and liver. ALT is released into the bloodstream as a result of tissue damage and in a variety of diseases involving the liver, such as hepatitis, cirrhosis, and mononucleosis.

V. Intended Use

A. Intended Use
The CARESIDE® ALT cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE® Analyzer to quantitatively measure ALT activity in anti-coagulated whole blood, plasma, or serum.
B. Indications for Use
For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.

{3}------------------------------------------------

VI. Technological Characteristics

A. Similarities

	CARESIDE ALT	Vitros ALT DT Slides
Intended Use	For in vitro diagnostic use.	For in vitro diagnostic use
Indications	Primarily to aid in thediagnosis and treatment ofpatients with certain types ofliver and heart disease.	Same
Measurement	Quantitative	Same
MethodPrinciple	Dry film based quantitation ofenzymatic activity byreflectance photometry usingPOP/POD coupling of ALTcatalyzed generation ofpyruvate	Dry film based. LDHcoupling of ALT catalyzedgeneration of pyruvate.
SpecimenDilution	Not required	Same
Materials	L-alanine, α-ketoglutaricacid, phosphoric acid,pyruvate oxidase, peroxidaseand diarylimidazole leucodye.	Lactate deydrogenase, L-alanine, sodium α-ketoglutarate, nicotinamideadenine dinucleotide reduced,and sodium pyridoxal-5-phosphate.
Detector	Reflectance (655 nm)	Reflectance (340 nm)
Test Time	Approx. 4-minute warm-up(on-board) plus 4 minute testtime.	15 minutes slide warm-up(off-line) plus 5 minutes testtime.
ReferenceMethod	NADH/NAD coupledreduction of pyruvate bylactate dehydrogenase	IFCC, 1978
Sample Type	Anti-coagulated whole blood,plasma, or serum	Same
SpecimenVolume	8.5µl test volume(90 ± 10 µl applied volume)	10 µl
Calibration	Calibration information bar-coded on each cartridge.Calibration information maychange with lot.	Run Vitros DT II calibratorswhenever a new slide lot isused or when necessary.
QualityControl	2 levels	Same
ReportingUnits	U/L	Same
ReactionTemp.	37 °C	Same
	CARESIDE ALT	Vitros ALT DT Slides
SpecimenPre-treatment	Not Required	Same
ReportableRange	15 – 1000 U/L	3 – 950 U/L
AccuratePipetting	Not required	Required
ReagentPre-warming	Not required	Required

{4}------------------------------------------------

April 30, 2002

B. Differences

C. Comparative Performance Characteristics

	CARESIDE ALT	Vitros ALT DT Slides
Detectionlimit	15 U/L	3 U/L
ReportableRange	15 - 1000 U/L	3 - 950 U/L
Accuracy	Mean recovery 106%	Not available
Precision	Total CV, 22 U/L, 4.5%	Total CV, 40 U/L, 9.5%
MethodComparison	CARESIDE® = 0.98 (BM/Hitachi 902) + 4.75 U/L, r =1.00
Linearity	Linearity by mixing yieldedslope and correlationcoefficient within acceptablelimits	Not available
Interference	No significant interferenceobserved at testedconcentration of interferent:Ascorbic Acid, 10 mg/dLBilirubin, 20 mg/dLTriglycerides 3000 mg/dLGamma globulin 4200 mg/dL	High gamma globulin

D. Conclusion

The nonclinical and clinical data provided demonstrate that the CARESIDE ALT product is as safe, effective, and performs as well as or better than the legally marketed predicate device.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.

Re:

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Renate A. MacLauren, Ph.D. Clinical Affairs Manager Careside 6100 Bristol Parkway Culver City, CA 90230

JUN 0 4 2002

K020487 Trade/Device Name: Careside® ALT Regulation Number: 21 CFR 862.1030 Regulation Name: Alanine amino transferase (ALT/SGPT) test system Regulatory Class: Class I, reserved Product Code: CKA Dated: April 30, 2002 Received: May 2, 2002

Dear Dr. MacLauren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours.

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

CARESIDE ALT Premarket Notification January 30, 2002

January 30, 2002

VI. INDICATIONS FOR USE

510(k) Number:

Device Name:

CARESIDE® ALT

KO20487

Indications for use: For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease

ean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

✓
Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.

(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.