(43 days)
K912844/A
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No
The document describes a standard in vitro diagnostic test cartridge and analyzer for measuring HDL-cholesterol. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic test cartridge used to measure HDL-cholesterol concentration, intended for diagnostic use, not direct treatment of a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "intended for in vitro diagnostic use" and "is indicated for use in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism."
No
The device description clearly states it is a "single use disposable in vitro diagnostic test cartridge" and a "film cartridge" containing reagents, which are physical hardware components. It is used in conjunction with an "Analyzer," also a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "intended for in vitro diagnostic use".
- Device Description: Describes a "single use disposable in vitro diagnostic test cartridge".
- Intended User/Care Setting: Indicates "For professional laboratory", which is a common setting for IVD use.
- Predicate Device(s): Lists a predicate device which is also an IVD (Vitros HDLC Slides).
All of these points clearly indicate that the CARESIDE™ HDL-Cholesterol cartridge is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Intended Use: The CARESIDE™ HDL-Cholesterol cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CARESIDE™ Analyzer to quantitatively measure HDL-cholesterol concentration in pre-treated serum or plasma.
- Indications for Use: This product is indicated for use in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism.
For in vitro diagnostic use with Exigent Diagnostics' CARESIDE™ Analyzer to measure HDL-cholesterol from pre-treated serum or plasma specimens to aid 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)
75LBS
Device Description
CARESIDE™ HDL-Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure HDL-cholesterol concentration in pre-treated serum or plasma specimens. The CARESIDE™ HDL-Cholesterol cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of pre-treated serum or plasma to a dry film to initiate the measurement of HDL-cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure HDL-cholesterol concentration.
Each Exigent Diagnostics CARESIDE™ HDL-Cholesterol cartridge consists of a HDL-cholesterol-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the pre-treated 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°C, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. Ten microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.
The ten microliters of pre-treated sample 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) to liberated 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 615 nanometers directly relates to the HDL-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 HDL-cholesterol concentration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The nonclinical and clinical data provided demonstrate that the CARESIDE™ HDL-Cholesterol 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.)
Detection limit: 10 mg/dL
Reportable range: 10 to 110 mg/dL
Accuracy: Mean recovery 109%
Precision: Total CV, 33 mg/dL, 6.5%
Method comparison: CARESIDE™ = 0.97 (Vitros HDLC DT) - 1.5 mg/dL, r = 0.97
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 - 9 g/dL Triglycerides 1500 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.
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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
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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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81899
Exigent Diagnostics, Inc. Page 11
CARESIDE™ HDL-Cholesterol Premarket Notification May 29, 1998
510(K) SUMMARY: CARESIDE™ HDL-CHOLESTEROL IV. SAFETY AND EFFECTIVENESS
I. Applicant Information
- A. Applicant Name
- Applicant/Manufacturer Address B.
- C. Telephone Number
- D. Contact Person
- E. FAX Number
- e-Mail Address F.
- Date 510(k) Summary prepared G.
II. Device Information
- A. Device Name (Trade)
- Device Name (Classification) B.
- 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 Mav 29, 1998
CARESIDE™ HDL-Cholesterol
HDL-Cholesterol test system Clinical chemistry panel HDL-Cholesterol test system Regulation Number: 21 CFR 862.1475 Regulatory Class I Classification Number: 75LBS 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.
HDL-Cholesterol in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market, including HDL-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™ HDL-Cholesterol test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of HDL-cholesterol on the Vitros DT 60 II.
| Name of Predicate Device: | Johnson and Johnson's (formerly Eastman Kodak,
Inc.) Vitros HDLC Slides for Johnson and Johnson's
Vitros DT 60 (formerly Eastman Kodak's DT 60 II). |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 510K number: | K912844/A |
| Product Code: | 75LBS |
1
IV. Device Description
CARESIDE™ HDL-Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure HDL-cholesterol concentration in pre-treated serum or plasma specimens. The CARESIDE™ HDL-Cholesterol cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of pre-treated serum or plasma to a dry film to initiate the measurement of HDL-cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure HDL-cholesterol concentration.
Explanation of Device Function A.
Each Exigent Diagnostics CARESIDE™ HDL-Cholesterol cartridge consists of a HDL-cholesterol-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the pre-treated 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°C, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. Ten microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.
The ten microliters of pre-treated sample 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) to liberated 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 615 nanometers directly relates to the HDL-cholesterol concentration of the specimen.
Test Reaction Sequence:
LPL> CHOL + CHOL-Ester+ Protein HDL-Cholesterol -CHOL-Ester - CHE > CHOL (free) -> H2O2 + Cholesten-3one CHOL + O2 + H2O -POD Fe+2 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 HDL-cholesterol concentration.
2
B. Test Summary
HDL-Cholesterol in blood comprises all of the cholesterol found in various lipoproteins. Cholesterol is the major component of the low-density lipoprotein fraction, and a minor component of the very low-density lipoprotein and high-density lipoprotein 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 LDLC 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. However, HDL- cholesterol concentration and cardiovascular disease risk are inversely related. Measurement of total and HDLcholesterol in serum is useful in evaluating cardiovascular disease risk.
V. Intended Use
-
A. Intended Use
The CARESIDE™ HDL-Cholesterol cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CARESIDE™ Analyzer to quantitatively measure HDL-cholesterol concentration in pre-treated serum or plasma. -
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
VI. Technological Characteristics
- Similarities A.
| | CARESIDE™
HDL-Cholesterol | Vitros HDLC DT Slides |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended Use | Primarily to aid in the diagnosis
and treatment of patients with
disorders of lipid and
lipoprotein metabolism. | Same |
| Indications | For in vitro diagnostic use.
For professional laboratory. | For in vitro diagnostic use |
| Measurement | Quantitative | Same |
| Method Principle | Dry film based already on the
U.S. market, including
HDL-cholesterol products
which utilize cholesterol
esterase sample treatment
followed by cholesterol oxidase
generation of hydrogen
peroxide from free and
liberated cholesterol which
reacts with a leuco dye in a
peroxidase catalyzed reaction to
form a blue dye. | Same |
| Specimen dilution | Not required | Same |
| Materials | Lipoprotein lipase, cholesterol
esterase, cholesterol oxidase,
peroxidase, and diarylimidazole
leuco dye | Cholesterol esterase,
cholesterol oxidase, peroxidase,
and diarylimidazole leuco dye |
| Detector | Reflectance (615 nm) | Reflectance (660 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 | Not known |
| Sample Type | Pre-treated serum or plasma | Same |
| 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 |
B. Differences
| | CARESIDE™
HDL-Cholesterol | Vitros HDLC DT Slides |
|----------------------------|------------------------------|-----------------------|
| Specimen pre-
treatment | Required | Required |
| Reportable range | 10 to 110 mg/dL | 1 to 110 mg/dL |
| Accurate
pipetting | Not required | Required |
| Reagent pre-
warming | Not required | Required |
4
、
Comparative Performance Characteristics C.
| | CARESIDE™
HDL-Cholesterol | Vitros HDLC DT Slides |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Detection limit | 10 mg/dL | 1 mg/dL |
| Reportable range | 10 to 110 mg/dL | 1 to 110 mg/dL |
| Accuracy | Mean recovery 109% | Not provided |
| Precision | Total CV, 33 mg/dL, 6.5% | Total CV, 41 mg/dL, 3.2% |
| Method
comparison | CARESIDE™ = 0.97 (Vitros HDLC DT) - 1.5 mg/dL, r = 0.97 | |
| 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 - 9 g/dL
Triglycerides 1500 mg/dL | Ascorbic Acid interferes
(non-interfering concentration
undefined) |
D. Conclusion
The nonclinical and clinical data provided demonstrate that the CARESIDE™ HDL-Cholesterol product is as safe, effective, and performs as well as or better than the legally marketed predicate device
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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circle's perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 4 1998
Kenneth B. Asarch, Ph.D. . VP Quality Systems and Regulatory Affairs Exigent Diagnostics Inc. 6100 Bristol Parkway 90230 Culver City, California
K981899 Re : CARESIDE™ HDL-Cholesterol Regulatory Class: I Product Code: LBS Dated: May 29, 1998 Received: June 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, 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, 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. ਸੋ 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 action. In addition, FDA may publish further announcements 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.
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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 requlation (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" Other general information on your (21 CFR 807.97). 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 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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VI. INDICATIONS FOR USE
510(k) Number:
Device Name:
CARESIDE™ HDL-Cholesterol
For in vitro diagnostic use with Exigent Diagnostics' CARESIDE™ Analyzer to Indications for use: measure HDL-cholesterol from pre-treated serum or plasma 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 | K981899 |
(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)
OR
Over-The-Counter Use (Optional Format 1-2-96)