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 human 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

The provided text describes the 510(k) summary for the Abbott Laboratories Calcium assay, comparing its performance to the Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by showing "acceptable correlation" and "substantially equivalent" performance to the predicate device. The performance metrics reported are correlation coefficient, slope, Y-intercept (for method comparison), and total %CV (for precision).

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Serum)	Reported Device Performance (Urine)
Method Comparison	"Acceptable correlation" to predicate device
Correlation Coefficient	High (close to 1)	0.9771	0.9987
Slope	Close to 1.0	1.011	1.039
Y-intercept	Close to 0	0.456 mg/dL	0.048 mg/dL
Precision (Total %CV)	Low (indicating good reproducibility)	Level 1: 1.7%, Level 2: 1.1%	Level 1: 1.4%, Level 2: 1.0%
Linearity	Covered the expected clinical range	Up to 27.24 mg/dL	Up to 30.8 mg/dL
Limit of Quantitation	Sufficiently low for clinical sensitivity	0.03 mg/dL	0.03 mg/dL

2. Sample Size and Data Provenance

Sample Size: The document does not explicitly state the specific number of samples (e.g., patient samples) used in the method comparison or precision studies. It mentions "two levels of control material" for precision studies.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications

This information is not provided in the given text. This type of information is typically not included in a 510(k) summary for an in vitro diagnostic assay, as the "ground truth" for quantitative assays is based on established reference methods and laboratory measurements, not expert consensus on interpretations.

4. Adjudication Method

This information is not provided in the given text, and is not applicable to an in vitro diagnostic assay where ground truth is established by quantitative measurement against a reference method or predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or other diagnostic tools where human interpretation is a key component, not for in vitro diagnostic assays.

6. Standalone Performance

The studies described are primarily standalone performance studies, demonstrating the algorithm's (assay's) performance characteristics (correlation, precision, linearity, sensitivity) against a predicate device and reference standards. The "assay" itself is the "algorithm" in this context. There is no human-in-the-loop component mentioned in these performance evaluations.

7. Type of Ground Truth Used

The ground truth for the test set was established by the predicate device (Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer) and reference standards for precision, linearity, and limit of quantitation. For quantitative assays like this, the "ground truth" is the accurately measured concentration of the analyte.

8. Sample Size for the Training Set

This information is not provided. For a traditional in vitro diagnostic chemical assay, the concept of a "training set" as understood in machine learning is not directly applicable. The assay itself is based on chemical reactions and optical measurements, not on a machine learning model trained on a dataset. Development and calibration might involve numerous samples, but it's not typically referred to as a "training set" in this context.

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

This information is not provided and is generally not applicable to this type of device. The "ground truth" for developing and calibrating such an assay would be based on precise chemical standards and established methodologies to ensure accurate measurement of calcium concentrations.

Summary

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1981578

Fax (972) 753-3367

JUN 1 6 1998

510(k) Summary

Contact Person Submitter's Name/Address Mark Littlefield Abbott Laboratories Section Manager MS 1-8 1920 Hurd Drive Regulatory Affairs Irving, Texas 75038 (972) 518-6062

May 1, 1998 Date of Preparation of this Summary: Ca Device Trade or Proprietary Name: Device Common/Usual Name or Classification Name: Calcium 75CLC/Class II Classification Number/Class:

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.

81578 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.
Calcium 510(k) May 1, 1998 Calciuf.lwp

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Both assays can be used for the quantitative determination of calcium. .
. Both assays vield 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 AEROSET™ System. 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 = 0.9771, slope = 1.011, and Y-intercept = 0.456 mg/dL. For the urine application, the correlation coefficient = 0.9987, slope = 1.039, and Y-intercept = 0.048 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 101 is 1.7% and Level 2/Panel 102 is 1.1%. For the urine application, the total % CV for Level 1/Panel 201 is 1.4% and Level 2/Panel 202 is 1.0%. The Calcium assay is linear up to 27.24 mg/dL for the serum application, and 30.8 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Calcium assay is 0.03 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.

Calcium 510(k) May 1, 1998 Calciuf two

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Conclusion:

動物用品の収益をついている。このコートレイト -

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

Calcium 510(k)
May 1, 1998 Calciuf.lwp

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The 1 6 1998

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

K981578 Re : Calcium Requlatory Class: II Product Code: CJY Dated: May 1, 1998 Received: May 4, 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 The general controls provisions of the Act 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 General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Fail Failure to In addition, FDA may publish further announcements action. 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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ছে তার

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 Litman

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): K981578

Calcium Device Name:

Indications For Use:

Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K981575

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

Concurrey se of CDRH, Office of Device Evaluation (ODE) 机 Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (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.