(58 days)
No
The device description and performance studies focus on a chemical reaction and spectrophotometric measurement, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used to measure total calcium levels in samples, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany".
No
The device description clearly states it is an "in vitro diagnostic assay" that uses a chemical reaction and measures color at a specific wavelength (660 nm). This indicates a physical reagent and a measurement instrument, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to measure the total calcium level in serum, plasma, and urine." These are biological samples taken in vitro (outside the body).
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay for the quantitation of Calcium in human serum, plasma, or urine." It describes the chemical reaction used to measure calcium in these samples.
- Purpose: The intended use also states that these measurements "are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany." This clearly indicates the device is used for diagnostic purposes based on testing samples in vitro.
The entire description aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of tissues and organs, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Calcium assay is used for the quantitation of Calcium in human serum, plasma, or urine.
A calcium test system is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Product codes
CJY
Device Description
Calcium is an in vitro diagnostic assay for the quantitation of Calcium in human scrum, plasma, or urine. Arscnazo-III dye reacts with calcium in an acid solution to form a blue-purple complex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.
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)
Comparative performance studies were conducted using the AEROSET and ARCHITECT c8000 Systems. The Calcium assay, LN 3L79, method comparison yielded acceptable correlation with the Abbott Calcium assay, LN 7D61, (K981578) on the AEROSET and ARCHITECT c8000 Systems (Predicate Device). The AEROSET System showed a correlation cocfficient of 0.9993, slope of 0.96, and Y-intercept of 0.31 mg/dL for the serum application and a correlation coefficient of 0.9994, slope of 0.95, and Y-interccpt of 0.17 mg/dL for the urine application when comparcd to the Predicate Device. The ARCHITECT c8000 System showed a correlation coefficient of 0.9989, slope of 0.96, and Y-intercept of 0.31 mg/dL for the serum application and a correlation coefficient of 0.9986, slope of 0.94, and Y-intercept of 0.17 mg/dL for the urine application when compared to the Predicate Device. The ARCHITECT c8000 System showed a correlation cocfficient of 0.9979, slope of 1.00, and Y-intercept of 0.04 mg/dL for the scrum application and a correlation coefficient of 0.9991, slope of 0.99, and Y-intercept of 0.00 mg/dL for the urine application when compared to the AEROSET System. The Calcium assay method comparison yielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.
Precision studies were conducted using the Calcium assay. On the AEROSET System, the total %CV for Level 1 is 1.01%, and Level 2 is 0.82% for the scrum application and the total %CV for Level 1 is 0.74%, and Level 2 is 0.65% for the urinc application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 1.23%, and Level 2 is 0.95% for the serum application and the total %CV for Level 1 is 0.72%, and Level 2 is 0.66% for the urinc application.
The Calcium assay is linear from 2 to 24 mg/dL for the serum and urinc applications. The Iimit of quantitation (sensitivity) of the Calcium assay is 1.0 mg/dL for the serum and urine applications.
These data demonstrate that the performance of the Calcium assay is substantially cquivalent to the performance of the Abbott Calcium assay, LN 7D61, (K981578) on the AEROSET and ARCHITECT Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The AEROSET System showed a correlation cocfficient of 0.9993, slope of 0.96, and Y-intercept of 0.31 mg/dL for the serum application and a correlation coefficient of 0.9994, slope of 0.95, and Y-interccpt of 0.17 mg/dL for the urine application when comparcd to the Predicate Device. The ARCHITECT c8000 System showed a correlation coefficient of 0.9989, slope of 0.96, and Y-intercept of 0.31 mg/dL for the serum application and a correlation coefficient of 0.9986, slope of 0.94, and Y-intercept of 0.17 mg/dL for the urine application when compared to the Predicate Device. The ARCHITECT c8000 System showed a correlation cocfficient of 0.9979, slope of 1.00, and Y-intercept of 0.04 mg/dL for the scrum application and a correlation coefficient of 0.9991, slope of 0.99, and Y-intercept of 0.00 mg/dL for the urine application when compared to the AEROSET System.
On the AEROSET System, the total %CV for Level 1 is 1.01%, and Level 2 is 0.82% for the scrum application and the total %CV for Level 1 is 0.74%, and Level 2 is 0.65% for the urinc application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 1.23%, and Level 2 is 0.95% for the serum application and the total %CV for Level 1 is 0.72%, and Level 2 is 0.66% for the urinc application.
The Calcium assay is linear from 2 to 24 mg/dL for the serum and urinc applications. The Iimit of quantitation (sensitivity) of the Calcium assay is 1.0 mg/dL for the serum and urine applications.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.
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510(k) Summary
NOV 2 2 2006
| Submitter's Name/Address | Contact Person |
|---|---|
| Abbott Laboratories | Linda Morris |
| 1921 Hurd Drive | Senior Regulatory Specialist, MS 2-1 |
| Irving, TX 75038 | Regulatory Affairs |
| (972) 518-6711 | |
| Fax (972) 518-7479 |
| Date of Preparation of this Summary: | September 18, 2006 |
|---|---|
| Device Trade or Proprietary Name: | Calcium |
| Device Common/Usual Name or | |
| Classification Name: | Calcium |
| Classification Number/Class: | Class II / 862.1145 |
| Product Code: | CJY |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K O (2855
Test Description:
Calcium is an in vitro diagnostic assay for the quantitation of Calcium in human scrum, plasma, or urine. Arscnazo-III dye reacts with calcium in an acid solution to form a blue-purple complex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.
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Substantial Equivalence:
The Calcium assay is substantially equivalent to the Abbott Calcium (K981578) on the AEROSET and ARCHITECT c8000 System. Both assays yicld similar Performance Characteristics.
Similarities:
- . Both assays are Arsenazo Dye Mcthodology.
- . Both assays can be used for the quantitation of Calcium.
- . Both assays vicld similar results.
- . Both assays use serum, plasma, and urine
Differences:
None
Intended Use:
The Calcium assay is used for the quantitation of Calcium in human serum, plasma, or urine.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET and ARCHITECT c8000 Systems. The Calcium assay, LN 3L79, method comparison yielded acceptable correlation with the Abbott Calcium assay, LN 7D61, (K981578) on the AEROSET and ARCHITECT c8000 Systems (Predicate Device). The AEROSET System showed a correlation cocfficient of 0.9993, slope of 0.96, and Y-intercept of 0.31 mg/dL for the serum application and a correlation coefficient of 0.9994, slope of 0.95, and Y-interccpt of 0.17 mg/dL for the urine application when comparcd to the Predicate Device. The ARCHITECT c8000 System showed a correlation coefficient of 0.9989, slope of 0.96, and Y-intercept of 0.31 mg/dL for the serum application and a correlation coefficient of 0.9986, slope of 0.94, and Y-intercept of 0.17 mg/dL for the
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urine application when compared to the Predicate Device. The ARCHITECT c8000 System showed a correlation cocfficient of 0.9979, slope of 1.00, and Y-intercept of 0.04 mg/dL for the scrum application and a correlation coefficient of 0.9991, slope of 0.99, and Y-intercept of 0.00 mg/dL for the urine application when compared to the AEROSET System. The Calcium assay method comparison yielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.
Precision studies were conducted using the Calcium assay. On the AEROSET System, the total %CV for Level 1 is 1.01%, and Level 2 is 0.82% for the scrum application and the total %CV for Level 1 is 0.74%, and Level 2 is 0.65% for the urinc application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 1.23%, and Level 2 is 0.95% for the serum application and the total %CV for Level 1 is 0.72%, and Level 2 is 0.66% for the urinc application.
The Calcium assay is linear from 2 to 24 mg/dL for the serum and urinc applications. The Iimit of quantitation (sensitivity) of the Calcium assay is 1.0 mg/dL for the serum and urine applications.
These data demonstrate that the performance of the Calcium assay is substantially cquivalent to the performance of the Abbott Calcium assay, LN 7D61, (K981578) on the AEROSET and ARCHITECT Systems.
Conclusion:
The Calcium assay on the AEROSET and the ARCHITECT c8000 Systems is substantially equivalent to the Abbott Calcium assay, LN 7D61, (K981578) on the AEROSET and ARCHITECT Systems as demonstrated by results obtained in the studies.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda Morris Senior Regulatory Specialist, MS 2-11 Abbott Laboratories 1921 Hurd Drive Iriving, TX 75038
NOV 2 2 2006
Re: K062855 Trade/Device Name: Calcium Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: September 18, 2006 Received: September 25, 2006
Dear Ms. Morris:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): k 06 2855
Device Name: Calcium
Indications For Use:
A calcium test system is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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