(51 days)
K912844/A
Not Found
No
The summary describes a dry film chemistry assay for measuring cholesterol, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is an in vitro diagnostic test for measuring total cholesterol, which aids in diagnosis and treatment but is not a therapeutic device itself.
Yes
The device is explicitly stated to be "For in vitro diagnostic use" and is intended "to aid in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism".
No
The device description explicitly states it is a "single use disposable in vitro diagnostic test cartridge" and a "film cartridge" containing reagents, indicating it is a physical hardware component used with an analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "For in vitro diagnostic use".
- Device Description: Describes the cartridges as "single use disposable in vitro diagnostic test cartridge".
- Function: The device is designed to measure a substance (total cholesterol) in biological specimens (whole blood, plasma, or serum) to aid in diagnosis and treatment. This is the core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Intended Use: The CARESIDE™ Total Cholesterol cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CARESIDE™ Analyzer to quantitatively measure total cholesterol concentration in anti-coagulated whole blood, plasma or serum.
- Indications for Use: This product is indicated for use in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism.
Product codes (comma separated list FDA assigned to the subject device)
75CHH, CHH
Device Description
CARESIDE™ Total Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure total cholesterol concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Total Cholesterol 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 total cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure total concentration of cholesterol. Each Exigent Diagnostics CARESIDE™ Total Cholesterol cartridge consists of a total cholesterol-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anti-coagulated 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, 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 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, and the sample moves through a reflection layer into the detection layer. Cholesterol is dissociated from protein by the action of lipoprotein lipase (LPL) and a surfactant. Cholesterol esterase (CHE) hydrolyzes the cholesterol esters (CHOL-ester) into free cholesterol. Endogenous cholesterol and the liberated cholesterol react with oxygen and water to produce hydrogen peroxide in a cholesterol oxidase (CO) catalyzed reaction. Peroxidase (POD) then catalyzes the reaction of the hydrogen peroxide with a diarylimidazole leuco dye to produce a blue chromogen. The color intensity of the resulting blue dye, as measured by the amount of reflected light at 505 nanometers, directly relates to the total cholesterol concentration of the specimen. As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate total cholesterol 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
For professional laboratory use.
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)
- Accuracy: Mean recovery 106%
- Precision: Total CV, 203 mg/dL, 5.2%
- Method comparison: CARESIDE™ = 1.04 (Vitros CHOL DT) + 23 mg/dL, r = 0.94
- 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 1 mg/dL, Bilirubin 10 mg/dL, Hemoglobin 250 mg/dL, Protein 5 to 9 g/dL, Triglyceride 600 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Detection limit: 50 mg/dL
- Reportable range: 50 to 450 mg/dL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K912844/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism 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.
0
111 2 / 1998
Exigent Diagnostics, Inc. Page 10
May 29, 1998
K982/118
510(K) SUMMARY: CARESIDE™ TOTAL IV. CHOLESTEROL SAFETY AND EFFECTIVENESS
Applicant Information I.
- Applicant Name A.
- Applicant/Manufacturer Address B.
- C. Telephone Number
- D. Contact Person
- E. FAX Number
- F. e-Mail Address
- Date 510(k) Summary prepared G.
II. Device Information
- A. Device Name (Trade)
- Device Name (Classification) B.
- C. Device Classification
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.
Total cholesterol in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market, including total cholesterol products which utilize enzymatic (cholesterol oxidase) generation of hydrogen peroxide from free and liberated cholesterol which reacts with chromogens in a peroxidase catalyzed reaction to form a dye.
- B. Specific equivalency claim
This CARESIDE™ Total Cholesterol test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of total cholesterol on the Vitros DT 60 II.
| Name of Predicate Device: | Johnson and Johnson's (formerly Eastman Kodak,
Inc.) Vitros CHOL Slides for Johnson and
Johnson's Vitros DT 60 (formerly Eastman Kodak's
DT 60 II). |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 510K number: | K912844/A |
| Product Code: | 75CHH |
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 May 29, 1998
CARESIDE™ Total Cholesterol
Total Cholesterol test system Clinical chemistry panel Total cholesterol test system Regulation Number: 21 CFR 862.1175 Regulatory Class I Classification Number: 75CHH None applicable
1
IV. Device Description
CARESIDE™ Total Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure total cholesterol concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Total Cholesterol 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 total cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure total concentration of cholesterol.
A. Explanation of Device Function
Each Exigent Diagnostics CARESIDE™ Total Cholesterol cartridge consists of a total cholesterol-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anti-coagulated 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, 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 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, and the sample moves through a reflection layer into the detection layer. Cholesterol is dissociated from protein by the action of lipoprotein lipase (LPL) and a surfactant. Cholesterol esterase (CHE) hydrolyzes the cholesterol esters (CHOL-ester) into free cholesterol. Endogenous cholesterol and the liberated cholesterol react with oxygen and water to produce hydrogen peroxide in a cholesterol oxidase (CO) catalyzed reaction. Peroxidase (POD) then catalyzes the reaction of the hydrogen peroxide with a diarylimidazole leuco dye to produce a blue chromogen. The color intensity of the resulting blue dye, as measured by the amount of reflected light at 505 nanometers, directly relates to the total cholesterol concentration of the specimen.
Test Reaction Sequence: Total Cholesterol ------------------------------------------------------------------------------------------------------------------------------------------------------------CHE -> CHOL (free) CHOL-Ester -CHOL + O2 + H2O2 + Cholesten-3one POD Fe .... > Blue dye Leuco dye + H2O2 -
As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate total cholesterol concentration.
2
Exigent Diagnostics, Inc. Page 12
B. Test Summary
Total cholesterol in blood comprises all of the cholesterol found in various lipoproteins. Cholesterol is the major component of the low density lipoprotein (LDL) fraction, and a minor component of the very low density lipoprotein (VLDL) and high density lipoprotein (HDL) fractions. Cholesterol measurements are used in classifying patients according to risk of coronary heart disease, in the diagnosis and treatment of various primary or secondary hyperlipidemias, and to monitor changes in cholesterol levels resulting from treatment. Elevated LDL-cholesterol has consistently been associated with incidence of atherosclerosis. There is also a strong correlation between considerably elevated cholesterol levels and an increased tendency for atherosclerosis. Conversely, HDL-cholesterol concentration and cardiovascular disease risk are inversely related. Measurement of total and HDL-cholesterol in serum is useful in evaluating cardiovascular disease risk.
V. Intended Use
-
A. Intended Use
The CARESIDE™ Total Cholesterol cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CARESIDE™ Analyzer to quantitatively measure total cholesterol concentration 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 disorders of lipid and lipoprotein metabolism.
3
i
VI. Technological Characteristics
- Similarities A.
| | CARESIDE™ Total
Cholesterol | Vitros CHOL DT Slides |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Primarily to aid in the diagnosis
and treatment of patients with
disorders of lipid and
lipoprotein metabolism. | Used in classifying patients
according to risk of coronary
heart disease, in the diagnosis
and treatment of various primary
or secondary hyperlipidemias,
and to monitor changes in
cholesterol and levels resulting
from treatment. |
| Indications | For in vitro diagnostic use.
For professional laboratory use. | For in vitro diagnostic use |
| Measurement | Quantitative | Same |
| Method Principle | Dry film based already on the
U.S. market, including total
cholesterol products which
utilize enzymatic (cholesterol
oxidase) generation - of
hydrogen peroxide from free
and liberated cholesterol
which reacts with chromogens
in a peroxidase catalyzed
reaction to form a dye. | Same |
| Specimen dilution | Not required | Same |
| Materials | Lipoprotein lipase, surfactant,
cholesterol esterase,
cholesterol oxidase,
peroxidase, and
diarylimidazole leuco dye | Surfactant, cholesterol
esterase, cholesterol oxidase,
peroxidase, and leuco dye |
| Detector | Reflectance (505 nm) | Reflectance (555 nm) |
| Test time | Approx. 4 minute warm-up (on-
board) plus 6 minute test time. | 15 minutes slide warm-up (off-
line) plus 5 minutes test time. |
| Reference Method | Abell Kendall | Abell Kendall |
| Sample Type | Serum, plasma, whole blood
[whole blood 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 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 |
| | CARESIDE™ Total
Cholesterol | Vitros CHOL DT Slides |
| Direct blood
specimen | Yes, whole blood | No, requires separation of
whole blood prior to sample
application |
| Reportable range | 50 to 450 mg/dL | 50 to 325 mg/dL |
| Accurate
pipetting | Not required | Required |
| Reagent pre-
warming | Not required | Required |
4
B. Differences
C. Comparative Performance Characteristics
| | CARESIDE™ Total
Cholesterol | Vitros CHOL DT Slides |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Detection limit | 50 mg/dL | 50 mg/dL |
| Reportable range | 50 to 450 mg/dL | 50 to 325 mg/dL |
| Accuracy | Mean recovery 106% | Not provided |
| Precision | Total CV, 203 mg/dL, 5.2% | Total CV, 202mg/dL, 3.4% |
| Method comparison | CARESIDE™ = 1.04 (Vitros CHOL DT) + 23 mg/dL, r = 0.94 | |
| 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 1 mg/dL
Bilirubin 10 mg/dL
Hemoglobin 250 mg/dL
Protein 5 to 9 g/dL
Triglyceride 600 mg/dL | Very high protein > 10 mg/dL |
D. Conclusion
The nonclinical and clinical data provided demonstrate that the CARESIDE™ Total Cholesterol product is as safe, effective, and performs as well as or better than the legally marketed predicate device
5
Image /page/5/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure embracing a bird, symbolizing care and protection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 24 1998
Kenneth B. Asarch, Ph.D. . VP Quality Systems and Regulatory Affairs Exigent Diagnostics Inc. 6100 Bristol Parkway Culver City, California 90230
K982118 Re: CARESIDE™ Total Cholesterol Regulatory Class: I Product Code: CHH Dated: May 29, 1998 June 3, 1998 Received:
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, Drug, 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 regulation (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 Register. 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 regulations.
6
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".
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
7
INDICATIONS FOR USE VI.
510(k) Number:
Device Name:
CARESIDE™ Total Cholesterol
Indications for use:
For in vitro diagnostic use with Exigent Diagnostics' CARESIDE™ Analyzer to measure total cholesterol from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982118
(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)