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).

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.

AI/ML Overview

The provided text describes the performance characteristics of the Abbott Laboratories Calcium assay (K062855) and its equivalence to a predicate device (Abbott Calcium assay, LN 7D61, K981578). This is an in vitro diagnostic assay, so the acceptance criteria and study data relate to analytical performance, not human-AI collaboration for image analysis.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it demonstrates performance by comparing it to a predicate device and showing acceptable correlation and precision. The "acceptance" is implicitly defined by the substantial equivalence to the predicate.

Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (K062855)
Correlation Coefficient (AEROSET vs. Predicate)	High correlation (e.g., typically >0.97 for method comparison for clinical assays)	Serum: 0.9993Urine: 0.9994
Slope (AEROSET vs. Predicate)	Close to 1.0	Serum: 0.96Urine: 0.95
Y-intercept (AEROSET vs. Predicate)	Close to 0	Serum: 0.31 mg/dLUrine: 0.17 mg/dL
Correlation Coefficient (ARCHITECT c8000 vs. Predicate)	High correlation	Serum: 0.9989Urine: 0.9986
Slope (ARCHITECT c8000 vs. Predicate)	Close to 1.0	Serum: 0.96Urine: 0.94
Y-intercept (ARCHITECT c8000 vs. Predicate)	Close to 0	Serum: 0.31 mg/dLUrine: 0.17 mg/dL
Overall Precision (AEROSET, Serum)	(Not explicitly stated, but typically low CV)	Level 1: 1.01% CVLevel 2: 0.82% CV
Overall Precision (AEROSET, Urine)	(Not explicitly stated, but typically low CV)	Level 1: 0.74% CVLevel 2: 0.65% CV
Overall Precision (ARCHITECT c8000, Serum)	(Not explicitly stated, but typically low CV)	Level 1: 1.23% CVLevel 2: 0.95% CV
Overall Precision (ARCHITECT c8000, Urine)	(Not explicitly stated, but typically low CV)	Level 1: 0.72% CVLevel 2: 0.66% CV
Linearity (Serum)	Within 2 to 24 mg/dL	2 to 24 mg/dL
Linearity (Urine)	Within 2 to 24 mg/dL	2 to 24 mg/dL
Limit of Quantitation (Sensitivity, Serum)	(Not explicitly stated, but typically low)	1.0 mg/dL
Limit of Quantitation (Sensitivity, Urine)	(Not explicitly stated, but typically low)	1.0 mg/dL

2. Sample size used for the test set and the data provenance

The document indicates "comparative performance studies were conducted" and "precision studies were conducted," but does not specify the sample sizes used for these studies. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is an in vitro diagnostic assay that measures a chemical concentration. Therefore, the concept of "experts" and "ground truth" in the context of image analysis or diagnostic interpretation by human readers does not apply. The ground truth for such devices is typically established through reference methods or by comparison to legally marketed predicate devices, which is the case here.

4. Adjudication method for the test set

Not applicable, as this is an in vitro diagnostic device measuring a chemical concentration, not a subjective interpretation requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human readers interpreting images or other data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done for the device (K062855) by comparing its results directly against the predicate device (K981578) and also between the two systems (AEROSET and ARCHITECT c8000). The reported performance characteristics (correlation, slope, Y-intercept, precision, linearity, sensitivity) reflect the algorithm's performance in quantitating Calcium. There is no human-in-the-loop component for this type of device.

7. The type of ground truth used

The ground truth was established by:

Comparison to a Legally Marketed Predicate Device: The performance of the new Calcium assay (K062855) was compared directly to "the Abbott Calcium assay, LN 7D61, (K981578) on the AEROSET and ARCHITECT c8000 Systems (Predicate Device)." This means the established performance of the predicate served as the reference for determining substantial equivalence.

8. The sample size for the training set

The document does not mention a training set or any machine learning/AI components. For a traditional in vitro diagnostic assay, there isn't a "training set" in the sense of AI model development. The assay's parameters would have been optimized during its development, but this process is not detailed here.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI model. For the development of the assay itself, the ground truth would typically be established through rigorous analytical chemistry principles and potentially reference methods, but this information is not provided in the summary.

Summary

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K062855

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 orClassification 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:

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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:

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)

Division Sign-Off

DIVISION Sign-Off

Page 1 of

Office of In Vit o Diagnostic Device Evaluation and Safety

K062855

Regulation Number and Section

§ 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.