PHOS

K981118 · Abbott Laboratories · CEO · Jun 12, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981118
• Device Name: PHOS
• Applicant: Abbott Laboratories
• Product Code: CEO · Clinical Chemistry
• Decision Date: Jun 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or urine.

Device Story

The Phosphorus assay is an in vitro diagnostic clinical chemistry test for the quantitative measurement of inorganic phosphorus in human serum, plasma, or urine. The assay utilizes a chemical reaction where inorganic phosphorus reacts with ammonium molybdate in dilute sulfuric acid to form an unreduced phosphomolybdate complex. The concentration of this complex is measured spectrophotometrically at 340 nm, with absorbance being directly proportional to the amount of inorganic phosphorus present. The assay is performed on automated chemistry analyzers (e.g., ALCYON Analyzer) in a clinical laboratory setting by trained laboratory personnel. The resulting quantitative output provides clinicians with data to assist in diagnosing and monitoring metabolic conditions related to parathyroid function, renal health, and vitamin D status.

Clinical Evidence

Bench testing only. Method comparison studies were conducted on the ALCYON Analyzer against Roche Cobas Mira Plus (serum) and Boehringer Mannheim (urine) assays. Serum correlation: r=0.9885, slope=1.049, intercept=0.264 mg/dL. Urine correlation: r=0.9947, slope=0.973. Precision studies (within-run, between-run, between-day) showed total %CVs between 2.4% and 3.2%. Linearity established up to 16 mg/dL; limit of quantitation is 0.3 mg/dL.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Principle: spectrophotometric measurement of unreduced phosphomolybdate complex at 340 nm. Reagents: ammonium molybdate in dilute sulfuric acid. Form factor: liquid reagents for use on automated clinical chemistry analyzers. Connectivity: dependent on host analyzer system. Sterilization: not applicable (reagent-based).

Indications for Use

Indicated for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine to aid in the diagnosis and treatment of disorders including parathyroid gland disease, kidney disease, and vitamin D imbalance.

Regulatory Classification

Identification

A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Predicate Devices

• Roche Cobas Mira Plus Phosphorus assay (K883962)
• Boehringer Mannheim Phosphorus Assay (K872494)

Submission Summary (Full Text)

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# 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: | March 26, 1998 |
|--------------------------------------------------|----------------|
| Device Trade or Proprietary Name: | Phos |
| Device Common/Usual Name or Classification Name: | Phosphorus |
| Classification Number/Class: | 75CEO/Class I |

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:

Phosphorus is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine. The Phosphorus assay is a clinical chemistry assay in which the inorganic phosphorus reacts with ammonium molybdate in dilute sulfuric acid to form the unreduced phosphomolybdate complex. The formation of the unreduced phosphomolybdate is measured at 340 nm and is directly proportional to the amount of inorganic phosphorus present.

## Substantial Equivalence:

The Phosphorus assay is substantially equivalent to the following devices:

- . Roche® Cobas Mira® Plus Phosphorus assay (K883962) for the serum application
- . Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 Analyzer for the urine application

Phosphorus 510(k) March 26, 1998 Phos326.lwg

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These assays yield similar Performance Characteristics.

Similarities to Roche:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of inorganic . phosphorus.
- Both assays yield similar clinical results. .

# Differences to Roche:

- There is a minor difference in the assay range. .
Similarities to Boehringer Mannheim:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of inorganic . phosphorus.
- . Both assays vield similar clinical results.

Differences to Boehringer Mannheim:

- . There is a minor difference in the assay range.
### Intended Use:

The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or urine.

## Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Phosphorus assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Phosphorus assay for the serum application and the Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9885, slope = 1.049, and the Y-intercept = 0.264 mg/dL. For the urine application, the correlation coefficient = 0.9947, slope = 0.973, and

Phosphorus 510(k) March 26, 1998 Phos326.lwp

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Y-intercept = - 1.582 mg/dL. Precision studies were conducted using the Phosphorus assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 111 control is 2.8% and Level 2/Panel 112 is 2.7%. For the urine application, the total %CV for Level 1/Panel 111 control is 3.2% and Level 2/Panel 112 is 2.4%. The Phosphorus assay is linear up to 16 mg/dL. The limit of quantitation (sensitivity) of the Phosphorus assay is 0.3 mg/dL. These data demonstrate that the performance of the Phosphorus assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Phosphorus assay for the serum application and the Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer for the urine application.

## Conclusion:

The Phosphorus assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Phosphorus assay for the serum application and the Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer for the urine application as demonstrated by results obtained in the studies.

Phosphorus 510(k) March 26, 1998 Phos326.lwp

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 12 1998

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

K981118 Re : Phosphorus I Regulatory Class: Product Code: CEO Dated: March 26, 1998 Received: March 27, 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 requlations 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 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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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 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Phosphorus

Indications For Use:

The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Lision. Clore. 0.62

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻨﺴﺎ Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use -----

(Optional Format 1-2-96)

00000006