CA

K981232 · Abbott Mfg., Inc. · CJY · May 18, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981232
• Device Name: CA
• Applicant: Abbott Mfg., Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: May 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

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 Story

In vitro diagnostic assay for quantitative calcium measurement in human serum, plasma, or urine. Uses arsenazo-III dye in acid solution to form blue-purple complex; color intensity measured at 600 nm is proportional to calcium concentration. Used in clinical laboratory settings by trained personnel. Output provides calcium concentration values to assist clinicians in diagnosing and managing parathyroid, bone, and renal diseases, as well as tetany.

Clinical Evidence

Bench testing only. Method comparison study against predicate (Hitachi 717) showed correlation coefficients of 0.9624 (serum) and 0.9981 (urine). Precision studies (within-run, between-run, between-day) reported total %CVs ranging from 1.7% to 6.8% across control levels. Linearity established up to 18 mg/dL; limit of quantitation is 0.865 mg/dL.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Principle: Arsenazo-III dye colorimetric reaction. Energy source: Photometric measurement at 600 nm. Form factor: Reagent-based assay for use on automated analyzers (e.g., ALCYON Analyzer).

Indications for Use

Indicated for the quantitative determination of calcium in human serum, plasma, or urine to aid in the diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease, and tetany.

Regulatory Classification

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).

Predicate Devices

• Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer (K850281)

Submission Summary (Full Text)

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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 [phone] Fax [phone]

| 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:

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.

### 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

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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).

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

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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)