(61 days)
K912844/A
CARESIDE Analyzer
No
The description details a chemical reaction and optical measurement process with calculations based on a standard curve, not AI/ML.
No
This device is an in vitro diagnostic (IVD) device used to measure triglyceride concentration, not to treat a condition. Its output, triglyceride levels, is used for diagnosis and treatment decisions, but the device itself does not perform therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the CARESIDE Triglyceride cartridge is "intended for in vitro diagnostic use" and "is indicated for use in the diagnosis and treatment of patients with primary or secondary hyperlipidemias."
No
The device description clearly outlines a physical cartridge containing reagents and a multi-layer film, which is inserted into an analyzer. This involves significant hardware components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "The CARESIDE Triglyceride cartridge is intended for in vitro diagnostic use..." It also describes its use in measuring triglycerides in biological specimens (whole blood, plasma, serum) for the diagnosis and treatment of hyperlipidemias.
- Device Description: The description details how the cartridge is used with the analyzer to perform a test on a biological specimen outside of the body. It describes the reagents and the process of measuring triglyceride concentration from the sample.
- Performance Studies: The document includes performance characteristics like accuracy, precision, method comparison, linearity, and interference, which are standard evaluations for IVD devices to demonstrate their reliability and validity for diagnostic purposes.
- Predicate Device: The mention of a predicate device (Johnson and Johnson's Vitros TRIG Slides) which is also an IVD, further supports the classification of the CARESIDE Triglyceride cartridge as an IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
CDT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Accuracy: Mean recovery 99%
- Precision: Total CV, 146 mg/dL, 3.4%
- Method comparison: CARESIDE= 0.98 (BM/Hitachi 902) + 2.92 mg/dL
- Linearity: Linearity by mixing and by dilution yielded slope and correlation coefficient within acceptable limits.
- Interference: No significant interference observed at tested concentration of interferent: Ascorbic acid, 10 mg/dL; Bilirubin, 10 mg/dL; Hemoglobin, 500 mg/dL
Predicate Device(s)
K912844/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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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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.
3
1
1
VI.
- Similarities A..
CARESIDE Triglyceride | Vitros TRIG DT Slides | |
---|---|---|
Intended Use | Primarily to aid in the diagnosis | |
and treatment of patients with | ||
primary or secondary | ||
hyperlipidemias. | Same | |
Indications | For in vitro diagnostic use. | For in vitro diagnostic use |
Measurement | Quantitative | Same |
Method Principle | Dry film based lipase | |
hydrolysis. Dye quantitated by | ||
reflectance measurement after | ||
fixed time. | Same | |
Specimen dilution | Not required | Same |
Materials | Lipoprotein lipase and coupling | |
enzymes and co-factors | Lipoprotein lipase and coupling | |
enzymes and co-factors (some | ||
same and some different) | ||
Detector | Reflectance (570 nm) | Reflectance (555 nm) |
Test time | Approx. 4 minutes warm-up | |
(on-board) plus 6 minute test | ||
time. | 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 may | ||
change with each lot. | Run Vitros DT II calibrators | |
whenever a new slide lot is | ||
used or when necessary. | ||
Quality Control | 2 levels | Same |
Reporting Units | mg/dL or mmol/L | Same |
Reaction Temp. | 37 °C | Same |
.
B. Differences
:
:
- September 2017
的手机 | be
CARESIDE Triglyceride | Vitros TRIG DT Slides | |
---|---|---|
Direct blood | ||
specimen | Yes, whole blood | No, requires separation of |
whole blood prior to sample | ||
application | ||
Reportable range | 25 to 500 mg/dL | 15 to 400 mg/dL |
Accurate | ||
pipetting | 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 by | |
dilution yielded slope and | ||
correlation coefficient within | ||
acceptable limits. | Not provided | |
Interference | No significant interference | |
observed at tested | ||
concentration of interferent: | ||
Ascorbic acid, 10 mg/dL | ||
Bilirubin, 10 mg/dL | ||
Hemoglobin, 500 mg/dL | None stated | |
Specimen Types & Anticoagulants | No clinically significant | |
difference between sodium | ||
heparinized whole blood, | ||
sodium heparin plasma, and | ||
EDTA plasma. Serum results | ||
are slightly higher. | No clinically significant | |
difference between serum, | ||
heparin plasma, or EDTA | ||
plasma. Whole blood is | ||
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: ________________________________________________________________________________________________________________________________________
6
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
8
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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