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 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Abbott Laboratories Phosphorus assay, which is an in vitro diagnostic device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting studies to meet such criteria for a new type of device. The information requested aligns more with the evaluation of AI/ML-driven medical devices or other devices where performance metrics like sensitivity, specificity, accuracy, and expert consensus are central to the acceptance criteria.

However, I can extract the information provided in the context of demonstrating substantial equivalence for this IVD, mapping it as closely as possible to your requested structure.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of IVD, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, meaning the new device should have "similar performance characteristics." The reported performance metrics are comparative.

Performance Metric	Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (Phosphorus Assay)
Serum Application:
Correlation Coefficient	Acceptable correlation with predicate device	0.9885 (vs. Roche Cobas Mira Plus Phosphorus assay)
Slope	Acceptable correlation with predicate device	1.049 (vs. Roche Cobas Mira Plus Phosphorus assay)
Y-intercept	Acceptable correlation with predicate device	0.264 mg/dL (vs. Roche Cobas Mira Plus Phosphorus assay)
Total %CV (Level 1)	Acceptable precision	2.8% (Level 1/Panel 111 control)
Total %CV (Level 2)	Acceptable precision	2.7% (Level 2/Panel 112 control)
Urine Application:
Correlation Coefficient	Acceptable correlation with predicate device	0.9947 (vs. Boehringer Mannheim Phosphorus assay on Hitatchi 717 Analyzer)
Slope	Acceptable correlation with predicate device	0.973 (vs. Boehringer Mannheim Phosphorus assay on Hitatchi 717 Analyzer)
Y-intercept	Acceptable correlation with predicate device	-1.582 mg/dL (vs. Boehringer Mannheim Phosphorus assay on Hitatchi 717 Analyzer)
Total %CV (Level 1)	Acceptable precision	3.2% (Level 1/Panel 111 control)
Total %CV (Level 2)	Acceptable precision	2.4% (Level 2/Panel 112 control)
General Performance:
Linearity	Acceptable range	Up to 16 mg/dL
Limit of Quantitation	Acceptable sensitivity	0.3 mg/dL

2. Sample size used for the test set and the data provenance

The document mentions "Comparative performance studies were conducted" and "Precision studies were conducted using the Phosphorus assay. Within-run, between-run, and between-day studies were performed using two levels of control material." However, it does not specify the sample size used for these studies (e.g., number of serum/urine samples, number of replicates).

The data provenance is not explicitly stated in terms of country of origin but is from "human serum, plasma, or urine." The studies appear to be prospective as they were conducted to demonstrate equivalence for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of IVD study. The "ground truth" (or reference method) is established by the predicate devices themselves (Roche Cobas Mira Plus Phosphorus assay and Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer), which are established clinical chemistry assays. There is no mention of experts establishing ground truth for individual samples.

4. Adjudication method for the test set

This information is not applicable. As it's a quantitative chemical assay, expert adjudication for results is not typically performed in the way it would be for image interpretation or diagnosis. The "reference" or "ground truth" values for comparison come from the predicate devices.

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

This is not applicable. MRMC studies are relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) often with AI assistance. This device is an in vitro diagnostic chemical assay, not an AI-assisted diagnostic tool.

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

This is not applicable in the context of an "algorithm only" device as described for AI/ML. The Phosphorus assay itself is a standalone chemical assay without human interpretation in the workflow of its quantitative result. Its performance is measured directly as an analytical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance comparison is the results obtained from legally marketed predicate devices:

Roche Cobas Mira Plus Automated Chemistry System Phosphorus assay (for serum)
Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer (for urine)

These predicate devices serve as the reference methods to which the new Phosphorus assay is compared.

8. The sample size for the training set

This information is not applicable to this type of IVD, as there is no "training set" in the context of machine learning or AI models. The assay is a chemical reaction-based method.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set.

Summary

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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 (972) 518-7861 Fax (972) 753-3367

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:

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 (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): ____________________________________________________________________________________________________________________________________________________

Device Name: Phosphorus

Indications For Use:

Lision. Clore. 0.62

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻨﺴﺎ Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use -----

(Optional Format 1-2-96)

00000006

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.