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.

Device 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 in the sample reacts with ammonium molybdate to form a heteropolyacid complex. The absorbance is measured at 340 nm and is directly proportional to the amount of inorganic phosphorus present in the sample.

AI/ML Overview

The Abbott Laboratories Phosphorus assay is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine. The device's performance was evaluated through comparative studies against the Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 Analyzer to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Serum)	Reported Device Performance (Urine)
Correlation Coefficient	Comparable to predicate	0.9939	0.9872
Slope	Comparable to predicate	1.067	1.040
Y-intercept	Comparable to predicate	0.166 mg/dL	0.970 mg/dL
Total %CV (Precision)	Comparable to predicate	Level 1: 1.1%, Level 2: 0.5%	Level 1: 1.6%, Level 2: 1.5%
Linearity (Upper Limit)	Comparable to predicate	25.3 mg/dL	186.2 mg/dL
Limit of Quantitation (Sensitivity)	Comparable to predicate	0.10 mg/dL	Not separately reported for urine

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for the comparative studies. The data provenance is not specified (e.g., country of origin, retrospective or prospective), but it can be inferred that the samples were human serum, plasma, or urine as per the intended use.

3. Number of Experts and Qualifications

Not applicable. This device is an in vitro diagnostic assay, and its performance is evaluated against a predicate device using analytical parameters rather than expert interpretation of results.

4. Adjudication Method

Not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessment.

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

Not applicable. This is an in vitro diagnostic assay for quantitative measurement, not an AI or imaging device requiring human-in-the-loop performance evaluation.

6. Standalone Performance Study

Yes, a standalone performance study was conducted to determine the device's characteristics such as precision, linearity, and limit of quantitation. These studies were performed using the AEROSET™ System.

7. Type of Ground Truth Used

The "ground truth" for comparison was the performance characteristics of a legally marketed predicate device, the Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 Analyzer. For precision, linearity, and sensitivity, the performance was established directly through the assays themselves, using control materials for precision and known concentrations for linearity and sensitivity.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm. The assay operates based on chemical reactions and photometric measurements, not a learned model from a training set.

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

Not applicable. There is no training set for this type of in vitro diagnostic assay.

Summary

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1981759

JUN 1 6 1998

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) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	May 18, 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:

Substantial Equivalence:

The Phosphorus assay is substantially equivalent to the following devices:

Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 . Analyzer
Phosphorus 510(k) May 18, 1998 Phos.lwp

Section II Page 1 0000011

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These assays yield similar Performance Characteristics.

Similarities:

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:

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 AEROSET™ System. The Phosphorus assay method comparison vielded acceptable correlation with the Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer. The correlation coefficient = 0.9939, slope = 1.067, and the Y-intercept = 0.166 mg/dL. For the urine application, the correlation coefficient = 0.9872, slope = 1.040, and Y-intercept = 0.970 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 101 control is 1.1% and Level 2/Panel 102 is 0.5%. For the urine application, the total %CV for Level 1/Panel 201 control is 1.6% and Level 2/Panel 202 is 1.5%. The Phosphorus assay is linear up to 25.3 mg/dL for the serum application, and 186.2 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Phosphorus assay is 0.10 mg/dL. These data demonstrate that the performance of the Phosphorus assay is substantially equivalent

Section II Page 2 0000012

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to the performance of the Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer for both serum and urine applications.

Conclusion:

and model and the comments of

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

Phosphorus 510(k) May 18, 1998 Phos.lwp

Section II Page 3

Property of the Property of

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The I 6 1898

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

Re : K981759 Phosphorus Requlatory Class: I Product Code: CEO Dated: May 18, 1998 Received: May 19, 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. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In additi m, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 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): _ Jag Sil 2 1 S 10(k) 1

Device Name: _________________________________________________________________________________________________________________________________________________________________ Phosphorus --------

Indications For Use:

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(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number. K981759

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Phosphorus 510(k) May 18, 1998 Phos.lwp

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510(k) Number (if known): _ Jog Stores 17 Sun

Device Name: _________________________________________________________________________________________________________________________________________________________________ Phosphorus

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K981759

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Phosphorus 510(k) May 18, 1998 Phos.lwp

म

Regulation Number and Section

§ 862.1580 Phosphorus (inorganic) test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.