The Calcium assay is used for the quantitation of calcium in human serum, plasma, or 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 quantitative determination of calcium in serum, plasma, or urine. The Calcium assay is a clinical chemistry assay in which arsenazo-III dye reacts with calcium in an acid solution to form a blue-purple complex. The color developed is measured at 600 nm and is proportional to the calcium concentration in the sample.

AI/ML Overview

Here's an analysis of the provided information regarding the Calcium assay, focusing on acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state "acceptance criteria" in a quantified manner beyond "acceptable correlation." Instead, it uses the performance of a predicate device as the benchmark for substantial equivalence.

Performance Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Calcium assay vs. Boehringer Mannheim Calcium on Hitachi 717)
Serum Application
Correlation Coefficient	Strong correlation (similar to predicate)	0.9624
Slope	Close to 1.0 (similar to predicate)	0.979
Y-intercept	Close to 0 (similar to predicate)	0.492 mg/dL
Within-run %CV (Level 1)	Low variability (similar to predicate)	1.7%
Within-run %CV (Level 2)	Low variability (similar to predicate)	2.9%
Overall Total %CV	Low variability (similar to predicate)	1.7% (Level 1) / 2.9% (Level 2)
Urine Application
Correlation Coefficient	Strong correlation (similar to predicate)	0.9981
Slope	Close to 1.0 (similar to predicate)	0.989
Y-intercept	Close to 0 (similar to predicate)	-0.094 mg/dL
Within-run %CV (Level 1)	Low variability (similar to predicate)	6.8%
Within-run %CV (Level 2)	Low variability (similar to predicate)	3.1%
Overall Total %CV	Low variability (similar to predicate)	6.8% (Level 1) / 3.1% (Level 2)
General
Linearity	Range similar to predicate	Up to 18 mg/dL
Limit of Quantitation (Sensitivity)	Similar to predicate	0.865 mg/dL
Clinical Results	Yield similar clinical results (Qualitative)	"Both assays yield similar clinical results."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the number of individual patient samples (test set) used for the comparative performance studies. It mentions "two levels of control material" for precision studies. For the method comparison, it implies a patient sample set was used to generate correlation, slope, and intercept, but the size is not quantified.
Data Provenance: Not specified. It's an in vitro diagnostic assay, so it's likely laboratory-based data. The country of origin and whether it's retrospective or prospective data are not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to a clinical chemistry assay like a calcium assay. The "ground truth" for a quantitative analyte is typically established by the reference method (in this case, the Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer) or by a highly accurate laboratory method. There are no human experts involved in visually interpreting or diagnosing based on the raw calcium measurement for ground truth establishment in this context.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison against a predicate device, not a diagnostic interpretation that requires expert adjudication.

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 not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or data. It's a quantitative in vitro diagnostic assay.

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

Yes, this study is inherently "standalone" in the sense that it evaluates the performance of the Calcium assay itself (the "algorithm" being the chemical reaction and measurement process) against a reference standard. There is no human interpretation or intervention in the measurement process itself that alters the output of the device.

7. The Type of Ground Truth Used

The ground truth or reference standard used for comparison is the Boehringer Mannheim® Calcium assay on the Hitachi® 717 Analyzer. This is a well-established, legally marketed predicate device, serving as the benchmark for acceptable performance. The study aims to demonstrate that the new Calcium assay yields "similar clinical results" and highly correlated quantitative measurements to this predicate.

8. The Sample Size for the Training Set

Not applicable in the context of this device. This is a traditional chemical assay, not a machine learning or AI-driven device that requires a "training set" in the computational sense. The assay's parameters (reagents, reaction conditions, measurement wavelength) are intrinsically defined by its chemical methodology, not by being "trained" on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable (as per point 8).

Summary

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K981232

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	April 2, 1998
Device Trade or Proprietary Name:	Ca
Device Common/Usual Name or Classification Name:	Calcium
Classification Number/Class:	75CLC/Class II

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:

Test Description:

Substantial Equivalence:

The Calcium assay is substantially equivalent to the Boehringer Mannheim® Calcium assay on the Hitachi® 717 Analyzer assay (K850281) for both the serum and urine applications.

Similarities to Boehringer Mannheim:

. Both assays are in vitro clinical chemistry methods.
Both assays can be used for the quantitative determination of calcium. .

Calcium 510(k) April 1, 1998 CalciuE2.lwp

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Both assays yield similar clinical results. .
Differences to Boehringer Mannheim:
There is a minor difference between the assay range. .

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 ALCYON™ Analyzer. The Calcium assay method comparison yielded acceptable correlation with the Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer. For the serum application, the correlation coefficient = 0.9624, slope = 0.979, and Y-intercept = 0.492 mg/dL. For the urine application, the correlation coefficient = 0.9981, slope = 0.989, and Y-intercept = - 0.094 mg/dL. Precision studies were conducted using the Calcium assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV is for Level 1/Panel 111 is 1.7% and Level 2/Panel 112 is 2.9%. For the urine application, the total % CV for Level 1/Panel 131 is 6.8% and Level 2/Panel 132 is 3.1%. The Calcium assay is linear up to 18 mg/dL. The limit of quantitation (sensitivity) of the Calcium assay is 0.865 mg/dL. These data demonstrate that the performance of the Calcium assay is substantially equivalent to the performance of the Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer for both serum and urine applications.

Conclusion:

The Calcium assay is substantially equivalent to the Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer for the serum, plasma, and urine applications as demonstrated by results obtained in the studies.

Calcium 510(k) April 1, 1998 CalciuE2.lwp

Section II Page 2

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 18 1998

Mark Littlefield Section Manager, Requlatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

K981232 Re : Calcium Regulatory Class: II Product Code: CJY Dated: April 2, 1998 Received: April 3, 1998

Dear Mr. Littlefield:

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 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. ಗಿ 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 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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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 Sitman

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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510(k) Number (if known):

Versi232

Calcium Device Name:

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981232

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﻬ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.