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 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. 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

CARESIDE Triglyceride Premarket Notification (K020488)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the CARESIDE Triglyceride device's performance characteristics against its predicate device (Vitros TRIG DT Slides) and general analytical standards. The document doesn't explicitly state "acceptance criteria" as a separate section, but rather presents performance characteristics of both devices side-by-side. The key areas of comparison are:

Characteristic	CARESIDE Triglyceride Performance (Reported)	Predicate Device (Vitros TRIG DT Slides) Performance	Implied Acceptance Criteria (relative to predicate)
Intended Use	Aid in diagnosis/treatment of hyperlipidemias	Same	Must be substantially equivalent
Indications	In vitro diagnostic use	In vitro diagnostic use	Must be substantially equivalent
Measurement Type	Quantitative	Quantitative	Must be quantitative
Method Principle	Dry film based lipase hydrolysis, reflectance	Same	Must be substantially equivalent
Specimen Dilution	Not required	Not required	Not required
Materials	Lipoprotein lipase and coupling enzymes/co-factors	Lipoprotein lipase and coupling enzymes/co-factors	Substantially equivalent (some same, some different)
Detector	Reflectance (570 nm)	Reflectance (555 nm)	Similar technology
Test Time	Approx. 4 min warm-up + 6 min test time	15 min warm-up + 5 min test time	Comparable or improved efficiency
Sample Type	Serum, plasma, whole blood	Serum, plasma	Broader (allowing whole blood) is considered an advantage and meets criteria
Specimen Volume	8.5 μl test volume (90 ± 10 μl applied)	10 μl	Comparable small volume required
Calibration	Bar-coded on each cartridge, lot-specific	Run Vitros DT II calibrators per new lot/as needed	Reliable and convenient calibration method
Quality Control	2 levels	Same	Standard QC practices
Reporting Units	mg/dL or mmol/L	Same	Standard clinical units
Reaction Temperature	37 °C	Same	Standard biological reaction temperature
Direct Blood Specimen	Yes, whole blood	No	Improved functionality, meets criteria
Reportable Range	25 to 500 mg/dL	15 to 400 mg/dL	Comparable or broader clinical range (improved upper limit, slightly higher lower)
Accurate Pipetting	Not required	Required	Improved ease of use, meets criteria
Reagent Pre-warming	Not required	Required	Improved ease of use, meets criteria
Detection Limit	25 mg/dL	15 mg/dL	Clinical relevance within range
Accuracy (Recovery)	Mean recovery 99%	Not provided	High accuracy demonstrated
Precision (Total CV)	3.4% at 146 mg/dL	2.1% at 189 mg/dL	Acceptable clinical precision
Method Comparison	CARESIDE = 0.98 (BM/Hitachi 902) + 2.92 mg/dL	r= 0.99 (implied against a reference method)	Strong correlation with a recognized reference method
Linearity	Slope and correlation coefficient within acceptable limits by mixing and dilution	Not provided	Demonstrated linearity across reportable range
Interference	No significant interference observed for tested interferents (Ascorbic acid, Bilirubin, Hemoglobin)	None stated	Demonstrated robustness against common interferents
Specimen Types (Anticoagulants)	No significant difference for sodium heparinized whole blood, sodium heparin plasma, EDTA plasma. Serum slightly higher.	No significant difference for serum, heparin plasma, or EDTA plasma. Whole blood unsuitable.	Demonstrated compatibility with relevant specimen types and anticoagulants, and an advantage with whole blood.

Study Proving Device Meets Acceptance Criteria:

The document describes a comparative performance characteristics study, though the details are somewhat summarized rather than a full protocol.

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

Sample Size: Not explicitly stated for each characteristic. For "Precision," a single sample concentration (146 mg/dL) is mentioned as tested. For "Method Comparison," the slope and intercept are provided, indicating a regression analysis was performed on a set of samples, but the number of samples is not stated. Similarly, for "Interference" and "Specimen Types & Anticoagulants," various conditions were tested, but specific sample numbers (n) are not given.
Data Provenance: Not explicitly stated. Given that it's a premarket notification for a US market, it's highly likely the data was generated in a lab environment (prospective testing) but the country of origin of the samples themselves is not specified.

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

Not Applicable. This is an in vitro diagnostic device for measuring a biochemical analyte (triglycerides). The "ground truth" for the test set would be established by a well-characterized reference measurement method (e.g., an assay on a high-precision clinical chemistry analyzer like the BM/Hitachi 902, or a gas chromatography-mass spectrometry method if available at the time for direct comparison). It does not involve human expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set:

Not Applicable. As this is a quantitative chemical assay, there is no human adjudication process involved in establishing the "ground truth" or comparing results. The comparisons are statistical and analytical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is relevant for diagnostic imaging or interpretation tasks where human readers make subjective assessments (e.g., radiologists reading scans). This device is an automated in vitro diagnostic assay, so MRMC studies are not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes. The entire performance characteristic section (Section IV.C. "Comparative Performance Characteristics") is effectively a standalone performance evaluation of the CARESIDE Triglyceride system (cartridge + Analyzer). The device is designed to be an automated measurement device, and the reported accuracy, precision, linearity, and method comparison data reflect its standalone performance. The document highlights features like "accurate pipetting not required" and "reagent pre-warming not required," which further emphasize its automated, standalone nature.

7. The Type of Ground Truth Used:

For Method Comparison, the ground truth was established by another well-accepted clinical chemistry analyzer, specifically the "BM/Hitachi 902." The comparison yielded the equation: CARESIDE = 0.98 (BM/Hitachi 902) + 2.92 mg/dL. This indicates the BM/Hitachi 902 served as the reference or comparative "ground truth" for evaluating the CARESIDE device's quantitative accuracy.
For Accuracy (Recovery), the ground truth would be the known concentration of triglycerides in spiked samples or certified reference materials, where the device's measured value is compared to the expected true value.
For Precision, the ground truth is the statistical property of repeatability and reproducibility, typically assessed by running samples multiple times to determine the variability (CV%).
For Linearity, the ground truth is derived from preparing samples with known serially diluted or mixed concentrations and ensuring the device's readings are proportional to these known values.

8. The Sample Size for the Training Set:

Not applicable / Not explicitly stated for this type of device. Clinical chemistry devices like this typically undergo extensive analytical validation (accuracy, precision, linearity, interference) using characterized samples. While there's an internal "lot-specific standard curve" mentioned for calibration, this isn't a "training set" in the machine learning sense. The device's underlying chemistry and optical detection principles are well-established. The development process would involve optimizing reagents and calibration, but the specific term "training set" with a defined sample size as used in AI/ML is not relevant here.

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

Not applicable for a "training set" in the AI/ML sense. For the calibration curves that the instrument uses, "ground truth" is established through carefully characterized calibrator materials with known triglyceride concentrations, measured by highly accurate reference methods. The device then generates a standard curve based on these calibrators to convert raw reflectance data into triglyceride concentrations.

Summary

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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 AsarchK@CARESIDE.com 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

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

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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VI.

Similarities A..

	CARESIDE Triglyceride	Vitros TRIG DT Slides
Intended Use	Primarily to aid in the diagnosisand treatment of patients withprimary or secondaryhyperlipidemias.	Same
Indications	For in vitro diagnostic use.	For in vitro diagnostic use
Measurement	Quantitative	Same
Method Principle	Dry film based lipasehydrolysis. Dye quantitated byreflectance measurement afterfixed time.	Same
Specimen dilution	Not required	Same
Materials	Lipoprotein lipase and couplingenzymes and co-factors	Lipoprotein lipase and couplingenzymes and co-factors (somesame and some different)
Detector	Reflectance (570 nm)	Reflectance (555 nm)
Test time	Approx. 4 minutes warm-up(on-board) plus 6 minute testtime.	15 minutes slide warm-up (off-line) plus 5 minutes test time.
Sample Type	Serum, plasma, whole blood[whole blood applied sample,plasma test sample]	Serum, plasma
Specimen volume	8.5 μl test volume(90 ± 10 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

B. Differences

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	CARESIDE Triglyceride	Vitros TRIG DT Slides
Direct bloodspecimen	Yes, whole blood	No, requires separation ofwhole blood prior to sampleapplication
Reportable range	25 to 500 mg/dL	15 to 400 mg/dL
Accuratepipetting	Not required	Required
Reagent pre-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 bydilution yielded slope andcorrelation coefficient withinacceptable limits.	Not provided
Interference	No significant interferenceobserved at testedconcentration of interferent:Ascorbic acid, 10 mg/dLBilirubin, 10 mg/dLHemoglobin, 500 mg/dL	None stated
Specimen Types & Anticoagulants	No clinically significantdifference between sodiumheparinized whole blood,sodium heparin plasma, andEDTA plasma. Serum resultsare slightly higher.	No clinically significantdifference between serum,heparin plasma, or EDTAplasma. Whole blood isunsuitable.

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 (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/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

RX X

OTC

Regulation Number and Section

§ 862.1705 Triglyceride test system.

(a)
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.(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.