The CareSide™ Glucose cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CareSide™ Analyzer to quantitatively measure glucose concentration in whole blood, plasma or serum by laboratory professionals. The CareSide™ Glucose test aids in the diagnosis and treatment of glucose regulation disorders such as diabetes.

For in vitro diagnostic use with Exigent Diagnostics' CareSide™ Analyzer to measure glucose from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and management of disorders of blood glucose regulation such as diabetes.

Device Description

CareSide™ Glucose cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure glucose concentration in whole blood, plasma or serum specimens. The CareSide™ Glucose cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of glucose concentration. The film cartridge (patent pending) contains all reagents necessary to measure glucose concentration.

Each Exigent Diagnostics CareSide™ Glucose cartridge consists of a glucose-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer.

Once loaded, the CareSide™ analyzer scans the cartridge barcode, spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers, and brings the cartridge and the contained specimen to 37℃. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well.

The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film. Protein is removed before the glucose solution diffuses through the reflection layer and reaches the reaction layer. In the reaction layer glucose reacts with oxygen via a glucose oxidasecatalyzed reaction to produce hydrogen peroxide which in turn participates in a peroxidase-catalyzed reaction with the substrate to produce a red dye. The color intensity, as measured by the amount of light reflected at 505 nanometers, is directly related to the specimen glucose concentration.

Test Reaction Sequence:

B-D-glucose + O2 + H2O __ slucoseoxidase > D-gluconic acid + H2O2 peroxiduse > Red dye 1,7-dihydroxynaphthalene + 4-aminoantipyrine + 2 H2O2-

As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate glucose concentration.

AI/ML Overview

The provided text describes the CareSide™ Glucose device and its premarket notification, including a comparison to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for various performance metrics. Instead, it presents performance characteristics and compares them to a predicate device, implying that performance "as well as or better than" the predicate device is the de facto acceptance criterion for substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implied)	Reported CareSide™ Glucose Performance	Predicate Device (Vitros Glucose DT) Performance
Detection Limit	≥ 20 mg/dL	20 mg/dL	20 mg/dL
Reportable Range	≥ 20 to 450 mg/dL	20 to 600 mg/dL	20 to 450 mg/dL
Accuracy	Comparable to Predicate	Mean recovery 98%	Not provided
Precision	Comparable to Predicate	Total CV, 94 mg/dL, 5.8%	Total CV, 117 mg/dL, 1.4%
Method Comparison	High correlation with Predicate	CareSide™ = 1.04 (Vitros Glucose DT) - 7.0 mg/dL, r = 1.00	N/A
Linearity	High correlation	Mean deviation approx 99%, r = 1.00	Not provided
Interference	Less or equal interference	No significant interference observed at tested concentrations of: Ascorbic Acid, Bilirubin, Creatinine, Hemoglobin, Protein, Triglycerides, Uric Acid	Interference observed for: Ascorbic acid, Hemoglobin @ 250 mg/dL, Protein < 5 g/dL, Protein > 10 g/dL
Specimen Types & Anticoagulants	Comparable utility	No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma.	No clinically significant difference between serum, heparin plasma, or EDTA plasma. Whole blood is unsuitable.
Expected Values	Comparable to Predicate	68 to 101 mg/dL (fasting)	65 - 110 mg/dL (fasting)

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

The document does not explicitly state the sample size used for the clinical test set. The data provenance is not specified, but it's implied to be retrospective as part of a 510(k) submission showcasing performance data that has already been collected. The studies appear to be laboratory-based evaluations rather than specific patient trials with details on country of origin.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. The performance data presented appears to be direct measurements and comparisons rather than subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader, multi-case (MRMC) comparative effectiveness study is mentioned. The device is an in vitro diagnostic (IVD) for quantitative measurement of glucose, not an imaging device or one requiring human reader interpretation in the same way. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context.

6. Standalone (Algorithm Only) Performance Study

Yes, the entire document is essentially a description of the standalone performance of the CareSide™ Glucose device (algorithm and integrated system) without human-in-the-loop performance influencing the measurement itself. The device is designed to quantitatively measure glucose.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is established by a "Reference Method" which is Hexokinase. This is a well-established enzymatic method for glucose measurement, considered a gold standard in clinical chemistry.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. As it refers to a device for quantitative chemical analysis, the "training set" might refer to samples used for initial calibration, method development, and optimization rather than a dataset for machine learning in the conventional sense.

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

The document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device (quantitative glucose measurement), it is highly probable that the ground truth for both training/development and testing would be established using a recognized reference method like the Hexokinase method, as indicated for the "Reference Method."

Summary

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MAY 7 1998

K981183

Exigent Diagnostics, Inc. Page 10

IV.

CareSide™ Glucose Premarket Notification March 31, 1998

CareSide™ Glucose Safety and 510(k) Summary: Effectiveness

I. Applicant Information

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

Device Information II.

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

Exigent Diagnostics, Inc.

6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 asarchk@worldnet.att.net March 31, 1998

CareSide™ Glucose

Glucose test system Clinical chemistry panel Glucose test system Regulation Number: 21 CFR 862.1345 Regulatory Class II Classification Number: 75CGA None applicable

D. Special controls and performance standards

III. Substantial Equivalence Claim

A. General equivalency claim
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.

Glucose in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market, including glucose products which utilize glucose oxidase catalyzed generation of hydrogen peroxide which enzymatically reacts with chromogens in a peroxidase catalyzed reaction to form a red dye.

B. Specific equivalency claim
This CareSide™ Glucose test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of glucose on the Vitros DT 60 II.

Name of Predicate Device:	Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros Glu Slides for Johnson and Johnson's Vitros DT 60 (formerly Eastman Kodak's DT 60 II).
Predicate Device 510K number:	K912844/A
Product Code:	75CGA

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IV. Device Description

A. Explanation of Device Function

Test Reaction Sequence:

B-D-glucose + O2 + H2O __ slucoseoxidase > D-gluconic acid + H2O2 peroxiduse > Red dye 1,7-dihydroxynaphthalene + 4-aminoantipyrine + 2 H2O2-

B. Test Summary

Determination of whole blood, serum or plasma glucose levels is important in the diagnosis and control of hypoglycemia, diabetes, nonketotic hyperglycemia, and various endocrine diseases of the pituitary and adrenal glands. Glucose is often measured as a tolerance test after the administration of doses of glucose or insulin. While clinical diagnoses should not be based upon glucose measurements alone, the following criteria for the diagnosis of diabetes mellitus have been proposed by the American Diabetes Association (ADA Glucose Guidelines Diabetes Care, Volume 20, Number 7, p. 1183-1197, July 1997), including: 126 mg/dL (fasting), 200 mg/mL (non-fasting with symptoms), 200 mg/dL (2-hour oral glucose tolerance).

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V. Intended Use

Intended Use A.
The CareSide™ Glucose cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CareSide™ Analyzer to quantitatively measure glucose concentration in whole blood, plasma or serum by laboratory professionals. The CareSide™ Glucose test aids in the diagnosis and treatment of glucose regulation disorders such as diabetes.
B. Indications for Use
This product is indicated for use with patients with glucose regulation disorders such as diabetes.

Technological Characteristics VI.

Similarities A.

	CareSide™ Glucose	Vitros Glucose DT Slides
Intended Use	Primarily to aid in the diagnosisand treatment of glucoseregulation disorders such asdiabetes.	Same
Indications	For in vitro diagnostic use.For laboratory professional use.	For in vitro diagnostic use
Measurement	Quantitative	Same
Method Principle	Dry film based glucose oxidasegeneration of hydrogenperoxide from glucose.Reaction of chromogen withhydrogen peroxide to form reddye. Dye quantitated byreflectance measurement afterfixed time.	Same
Specimen dilution	Not required	Same
Materials Source	Glucose oxidase fromAspergillus niger ; peroxidasefrom horseradish	Glucose oxidase, peroxidase:sources unknown
Detector	Reflectance (505 nm)	Reflectance (555 nm)
Test time	Approximately 4 minute warm-up (on-board) plus 5 minute testtime.	15 minutes slide warm-up (off-line) plus 5 minutes test time.
Reference Method	Hexokinase	Hexokinase
Sample Type	Serum, plasma, whole blood(wb) [wb applied sample,plasma test sample]	serum, plasma
Specimen volume	10 µl test volume(85 ± 15 µl applied volume)	10 µl
Calibration	Calibration information bar-coded on each cartridge.Calibration information maychange with each lot.	Run Vitros DT II calibratorswhenever a new slide lot isused or when necessary.
Quality Control	2 levels	Same
Reporting Units	mg/dL or mmol/L	Same
Reaction Temp.	37 °C	Same

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B. Differences

	CareSide™ Glucose	Vitros Glucose DT Slides
Direct bloodspecimen	Yes, whole blood	No, requires separation ofwhole blood prior to sampleapplication
Reportable range	20 to 600 mg/dL	20 to 450 mg/dL
Accuratepipetting	Not required	Required
Reagent pre-warming	Not required	Required

Comparative Performance Characteristics C.

	CareSide™ Glucose	Vitros Glucose DT Slides
Detection limit	20 mg/dL	20 mg/dL
Reportable range	20 to 600 mg/dL	20 to 450 mg/dL
Accuracy	Mean recovery 98%	Not provided
Precision	Total CV, 94 mg/dL, 5.8%	Total CV, 117 mg/dL, 1.4%
Method comparison	CareSide™ = 1.04 (Vitros Glucose DT) - 7.0 mg/dL, r = 1.00
Linearity	Mean deviation approx 99%,r = 1.00	Not provided
Interference	No significant interference observed at tested concentration of interferent:Ascorbic Acid, 20 mg/dLBilirubin, 20 mg/dLCreatinine, 40 mg/dLHemoglobin, 500 mg/dLProtein 3.5 - 9.5 g/dLTriglycerides 3000 mg/dLUric Acid 20 mg/dL	Interference observed for:Asocrbic acidHemolgobin @ 250 mg/dLProtein < 5 g/dLProtein > 10 g/dL
Specimen Types & Anticoagulants	No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma.	No clinically significant difference between serum, heparin plasma, or EDTA plasma. Whole blood is unsuitable.
Expected Values	68 to 101 mg/dL (fasting)Central 95% interval	65 - 110 mg/dL (fasting)Central 95% interval

D. Conclusion

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

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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 7 1998

Kenneth B. Asarch, Ph.D. VP Quality Systems and Regulatory Affairs Exigent Diagnostics Inc. 6100 Bristol Parkway 90230 Culver City, California

K981183 Re : CareSide™ Glucose Regulatory Class: II Product Code: CGA Dated: March 31, 1998 Received: April 1, 1998

Dear Dr. Asarch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" a

Sincerely yours,
Steven Litman

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

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Exigent Diagnostics, Inc.

Page 15

CareSide™ Glucose Premarket Notification Revised April 22, 1998

Indications for Use

510(k) Number:

Device Name:

CareSide™ Glucose

Indications for use:

(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 Eormat 1-2-96) (Division Sign-Off) Division of Clinical Laboratory 510(k) Number C

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.