CARESIDE TRGLYCERIDE

K020488 · Careside, Inc. · CDT · Apr 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020488
• Device Name: CARESIDE TRGLYCERIDE
• Applicant: Careside, Inc.
• Product Code: CDT · Clinical Chemistry
• Decision Date: Apr 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Intended Use

The CARESIDE Triglyceride cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer to quantitatively measure the concentration of triglycerides in anti-coagulated whole blood, plasma or serum. This product is indicated for use in the diagnosis and treatment of patients with primary or secondary hyperlipidemias. Hyperlipidemias may result from liver obstruction, diseases involving lipid metabolism, or various endocrine disorders. Triglyceride results are used together by the CARESIDE Analyzer with total cholesterol and HDL-cholesterol results to calculate LDL-cholesterol levels.

Device Story

CARESIDE Triglyceride cartridge is a single-use, disposable in vitro diagnostic test used with the CARESIDE Analyzer. User introduces anticoagulated whole blood, serum, or plasma into cartridge sample well. Analyzer automatically separates blood cells via centrifugation, meters plasma/serum, and dispenses it onto a multi-layer reagent film. Triglyceride concentration is measured via lipase hydrolysis coupled to a glycerol kinase-based reflectance system. Photodiodes measure reflectance of light emitted by LEDs at 570 nm. Instrument uses lot-specific standard curve to calculate concentration. Results are used by clinicians to diagnose/treat hyperlipidemias and calculate LDL-cholesterol levels. Benefits include rapid, point-of-care quantitative measurement without manual sample dilution or pre-separation.

Clinical Evidence

Bench testing only. Method comparison against BM/Hitachi 902 yielded r=0.98, slope 0.98, intercept 2.92 mg/dL. Precision (total CV) 3.4% at 146 mg/dL. Mean recovery 99%. Interference testing showed no significant interference from ascorbic acid (10 mg/dL), bilirubin (10 mg/dL), or hemoglobin (500 mg/dL).

Technological Characteristics

Multi-layer reagent film in plastic cartridge. Sensing principle: lipase hydrolysis coupled to glycerol kinase-based reflectance detection. Light source: LED (570 nm). Connectivity: barcode-scanned calibration. Operational temp: 37°C. Sample volume: 8.5 μL (metered).

Indications for Use

Indicated for diagnosis and treatment of patients with primary or secondary hyperlipidemias (e.g., liver obstruction, lipid metabolism diseases, endocrine disorders). Used with CARESIDE Analyzer to measure triglycerides in anti-coagulated whole blood, plasma, or serum.

Regulatory Classification

Identification

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Predicate Devices

• Vitros TRIG Slides for Johnson and Johnson's Vitros DT 60 (K912844/A)

Submission Summary (Full Text)

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APR 1 5 2002

CARESIDE, Inc. January 31, 2002

CARESIDE Triglyceride Premarket Notification

K020488 Page 10

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

#### I. Applicant Information

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

#### II. Device Information

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

CARESIDE, Inc.

6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-670-6986 [e-mail] January 31, 2002

CARESIDE Triglyceride Triglyceride test system Clinical chemistry panel Triglyceride test system Regulation Number: 21 CFR 862.1705 Regulatory Class I Classification Number: 75CDT None applicable

- Special controls and D. 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.

Triglyceiide in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market, including triglyceride products which utilize lipase hydrolysis coupled to a glycerol kinase based reflectance detection system for glycerol.

#### B. Specific equivalency claim

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

Name of Predicate Device:

Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros TRIG Slides for Johnson and Johnson's Vitros DT 60 (formerly Eastman Kodak's DT 60 II).

Predicate Device 510K number: Product Code:

K912844/A 75CDT

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#### IV. Device Description

CARESIDE Trighceride cartridges are used with the CARESIDE Analyzer to measure triglyceride concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE Triglyceride 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 triglyceride concentration. The patented film cartridge contains all reagents necessary to measure triglyceride concentration.

#### A. Explanation of Device Function

Each CARESIDE Triglyceride cartridge consists of a triglyceride-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anticoagulated whole blood, serum, or plasma 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 deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately 8.5 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 The triglyceride-containing specimen is distributed uniformly by the reagent film. spreading layer. The sample then passes through a reflection layer and into the reaction layer. Finally, the reaction mixture is pulled through the reaction layer by a suction layer where the NTB chromogen is converted into a purple formazan dye.

As the cartridge spins, a photodiode measures film reflectance of light emitted from a wavelength-specific light emitting diode (LED) at a lixed time. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate triglyceride concentration.

Test Reaction Sequence:

LPL > Glycerol + Fatty Acid Triglycerides -

GK Ms++> G-3-P + ADP Glycerol + ATP =

G-3-P + NAD+ -- -- 3-10->DHAP + NADH

NTB + NADH -- 2:iuphorsse > Formazan dye + NAD*

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

#### B. Test Summary

Triglycerides, consisting of fatty acids in ester linkages with glycerol, are the major form of fat found in the body. The primary function of triglyceride is to store energy.

Elevated triglycerides in patients reflect primary disorders of lipid metabolism or hyperlipoproteinemia secondary to known diseases including diabetes mellitus, nephrosis, biliary obstruction, pancreatitis and metabolic disorders associated with endocrine disturbances. Elevated levels of triglycerides has been identified as a risk factor related to atherosclerotic disease leading to coronary heart disease. Plasma levels of triglycerides can vary independently of lipoprotein levels; therefore evaluation of hyperlipidemias should include determinations of triglycerides.

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Page 12

#### V. Intended Use

#### A. Intended Use

The CARESIDE Triglyceride cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer to quantitatively measure the concentration of triglycerides in anti-coagulated whole blood, plasma or serum.

#### B. Indications for Use

This product is indicated for use in the diagnosis and treatment of patients with primary or secondary hyperlipidemias. Hyperlipidemias may result from liver obstruction, diseases involving lipid metabolism, or various endocrine disorders. Triglyceride results are used together by the CARESIDE Analyzer with total cholesterol and HDL-cholesterol results to calculate LDL-cholesterol levels.

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1

1

## VI.

- Similarities A..

| | CARESIDE Triglyceride | Vitros TRIG DT Slides |
|-------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | Primarily to aid in the diagnosis<br>and treatment of patients with<br>primary or secondary<br>hyperlipidemias. | Same |
| Indications | For in vitro diagnostic use. | For in vitro diagnostic use |
| Measurement | Quantitative | Same |
| Method Principle | Dry film based lipase<br>hydrolysis. Dye quantitated by<br>reflectance measurement after<br>fixed time. | Same |
| Specimen dilution | Not required | Same |
| Materials | Lipoprotein lipase and coupling<br>enzymes and co-factors | Lipoprotein lipase and coupling<br>enzymes and co-factors (some<br>same and some different) |
| Detector | Reflectance (570 nm) | Reflectance (555 nm) |
| Test time | Approx. 4 minutes warm-up<br>(on-board) plus 6 minute test<br>time. | 15 minutes slide warm-up (off-<br>line) plus 5 minutes test time. |
| Sample Type | Serum, plasma, whole blood<br>[whole blood applied sample,<br>plasma test sample] | Serum, plasma |
| Specimen volume | 8.5 μl test volume<br>(90 ± 10 μl applied volume) | 10 μl |
| Calibration | Calibration information bar-<br>coded on each cartridge.<br>Calibration information may<br>change with each lot. | Run Vitros DT II calibrators<br>whenever a new slide lot is<br>used or when necessary. |
| Quality Control | 2 levels | Same |
| Reporting Units | mg/dL or mmol/L | Same |
| Reaction Temp. | 37 °C | Same |

.

#### B. Differences

:

:

1. September 2017

的手机 | be

| | CARESIDE Triglyceride | Vitros TRIG DT Slides |
|--------------------------|-----------------------|--------------------------------------------------------------------------|
| Direct blood<br>specimen | Yes, whole blood | No, requires separation of<br>whole blood prior to sample<br>application |
| Reportable range | 25 to 500 mg/dL | 15 to 400 mg/dL |
| Accurate<br>pipetting | Not required | Required |
| Reagent pre-<br>warming | Not required | Required |

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Page 14

# Comparative Performance Characteristics

| | CARESIDE Triglyceride | Vitros TRIG DT Slides |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Detection limit | 25 mg/dL | 15 mg/dL |
| Reportable range | 25 to 500 mg/dL | 15 to 400 mg/dL |
| Accuracy | Mean recovery 99% | Not provided |
| Precision | Total CV, 146 mg/dL, 3.4% | Total CV, 189 mg/dL, 2.1% |
| Method comparison | CARESIDE= 0.98 (BM/Hitachi 902) + 2.92 mg/dL | r= 0.99 |
| Linearity | Linearity by mixing and by<br>dilution yielded slope and<br>correlation coefficient within<br>acceptable limits. | Not provided |
| Interference | No significant interference<br>observed at tested<br>concentration of interferent:<br>Ascorbic acid, 10 mg/dL<br>Bilirubin, 10 mg/dL<br>Hemoglobin, 500 mg/dL | None stated |
| Specimen Types & Anticoagulants | No clinically significant<br>difference between sodium<br>heparinized whole blood,<br>sodium heparin plasma, and<br>EDTA plasma. Serum results<br>are slightly higher. | No clinically significant<br>difference between serum,<br>heparin plasma, or EDTA<br>plasma. Whole blood is<br>unsuitable. |

#### D. Conclusion

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

- C.
1000

.

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Page 15

# PREMARKET NOTIFICATION TRUTHFUL AND V. ACCURATE STATEMENT

[As required by 21 CFR 807.87(j)]

I certify that, in my capacity as the VP Quality Systems and Regulatory Affairs of CARESIDE, Inc., I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

| Signature: | Kenneth B. Asarch |
|------------|-----------------------------------|
| | Kenneth B. Asarch, Pharm.D, Ph.D. |
| Date: | January 31, 2002 |

(to be assigned.) Premarket notification 510(k) Number: ________________________________________________________________________________________________________________________________________

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble human figures or flowing lines.

### Public Health Service

Food and Drug Administration 2098 Gaither Road i Rockville MD 20850

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

APR 1 5 2002

Re: k020488

> Trade/Device Name: CARESIDE Triglyceride Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride test system Regulatory Class: Class I. reserved Product Code: CDT Dated: January 31, 2002 Received: February 13, 2002

Dear Dr. Asarch:

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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Steven Butman

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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CARESIDE, Inc. January 31, 2002

CARESIDE Triglyceride Premarket Notification

Page 16

### INDICATIONS FOR USE VI.

510(k) Number:

#### Device Name: CARESIDE Triglyceride

For in vitro diagnostic use with the CARESIDE Analyzer to Indications for use: measure triglycerides in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE Triglyceride test aids in the diagnosis and treatment of patients with primary or secondary hyperlipidemias (hyperlipidemias may result from liver obstruction, diseases involving lipid metabolism, or various endocrine disorders. Triglyceride results are used together by the CARESIDE Analyzer with total cholesterol and HDL-cholesterol results to calculate LDL-cholesterol levels).

(Division Sign-Off)
Division of Clinical Labora
510(k) Number K020488

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OTC