(71 days)
K912844/A
K912844/A
No
The document describes a quantitative in vitro diagnostic test and analyzer, focusing on chemical reaction measurement and comparison to predicate devices, with no mention of AI or ML terms or concepts.
No
The device is described as being for "in vitro diagnostic use" to measure AST, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use."
No
The device is described as being for in vitro diagnostic use with the CARESIDE Analyzer™, which is a hardware device. The summary focuses on the performance of the assay in conjunction with this analyzer, not as a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first section explicitly states "For in vitro diagnostic use". It also describes measuring AST from biological specimens (whole blood, plasma, or serum) for the diagnosis and treatment of patients. This is the core definition of an in vitro diagnostic device.
- Specimen Type: The device analyzes biological specimens (whole blood, plasma, or serum), which is characteristic of IVDs.
- Purpose: The purpose is to "quantitatively measure AST" to aid in "the diagnosis and treatment of patients". This is a diagnostic purpose.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure AST from anti-coagulated whole blood, plasma, or serum specimens to measure AST from and-coagulated with croos, pertain types of liver and heart ald in the diagnosis and treatment of patients with ouse: not for point of care or physician office laboratory use.
Product codes
75CIT, CIT
Device Description
CARESIDE™ AST is an Aspartate amino transferase test system used in clinical chemistry panels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not for point of care or physician office laboratory use.
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
A quantitative method comparison is provided to the Raichem Aspartate Aminotransferase method and the Sigma Diagnostics Aspartate Aminotransferase method rather than the Vitros method because the CARESIDE, Raichem, and Sigma Diagnostics methods all measure the reaction without supplementation of the co-factor pyridoxal-5-phosphate.
Key Metrics
Not Found
Predicate Device(s)
K912844/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image shows a handwritten date of 3/15/99 at the top left. Below the date, the text "CARESIDE, Inc." is printed in bold. Underneath "CARESIDE, Inc.", the text "Page 10" is printed.
K 99009
510(K) SUMMARY: CARESIDE™ AST SAFETY AND IV. EFFECTIVENESS
I. Applicant Information
- A. Applicant Name
- Applicant/Manufacturer Address B.
- C. Telephone Number
- Contact Person D.
- FAX Number E.
- F. e-Mail Address
- Date 510(k) Summary prepared G.
Device Information II.
- 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. 310-338-6789 AsarchK@CARESIDE.com December 30, 1998
CARESIDE™ AST
Aspartate amino transferase test system Clinical chemistry panel Aspartate amino transferase test system Regulation Number: 21 CFR 862.1100 Regulatory Class II Classification Number: to be assigned 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.
AST in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market.
- B. Specific equivalency claim
The CARESIDE™ AST test is substantially equivalent in its principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of AST on the Vitros DT 60 II / DTSC II. A quantitative method comparison is provided to the Raichem Aspartate Aminotransferase method and the Sigma Diagnostics Aspartate Aminotransferase method rather than the Vitros method because the CARESIDE, Raichem, and Sigma Diagnostics methods all measure the reaction without supplementation of the co-factor pyridoxal-5-phosphate. Whereas, the Vitros DT 60 II method uses pyridoxal-5-phosphate supplementation and thus is expected to yield higher results.
Johnson and Johnson's (formerly Eastman Kodak, Name of Predicate Device: Inc.) Vitros AST DT Slides for Johnson and Johnson's Vitros DT 60 II / DTSC II (formerly Eastman Kodak's DT 60 II).
Predicate Device 510K number: K912844/A Product Code: 75CIT
1
MAR 1 6 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth B. Asarch, Pharm.D., Ph.D. VP Quality Systems and Regulatory Affairs CARESIDE, INC. 6100 Bristol Parkway Culver City, CA 90230
K990009 Re: Trade Name: CARESIDE™ AST Regulatory Class: II Product Code: CIT Dated: December 30, 1998 Received: January 4, 1999
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 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). 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 (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. A 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 requlation 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 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/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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
3
INDICATIONS FOR USE VI.
510(k) Number:
K9990009 CARESIDE™ AST
Device Name:
Indications for use:
For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure AST from anti-coagulated whole blood, plasma, or serum specimens to measure AST from and-coagulated with croos, pertain types of liver and heart ald in the diagnosis and treatment of patients with ouse: not for point of care or physician office laboratory use.
Jean Cooger
(Division Sign-Off)
Division of Clinical
(Division of Clinical Laboratory Devices
510(k) Number 510(k) Number _ K 990 009
(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)
Over-The-Counter Use (Optional Format 1-2-96)