The Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus reagent is intended for use for the quantitative in vitro determination of phosphorus in human serum, plasma and urine with automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1580, 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.

Device Description

Endpoint method with sample blanking.

Inorganic phosphate forms an ammonium phosphomolybdate complex with ammonium molybdate in the presence of sulfuric acid. The complex is determined photometrically in the ultraviolet region (340 nm).

AI/ML Overview

The provided text describes the 510(k) summary for the Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus Reagent. This submission seeks substantial equivalence to an existing device, focusing on extended claims for specimen collection, reportable range (urine), imprecision, and method comparison (urine).

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. A table of acceptance criteria and the reported device performance:

The document describes the changes and similarities to the predicate device but does not explicitly state specific acceptance criteria (e.g., performance targets, accuracy thresholds) or provide a table directly comparing acceptance criteria with reported device performance for the extended claims.

However, it implicitly refers to performance characteristics for the extended claims. The "Limitations - Interferences" section provides some performance details related to interference, which could be considered partial performance data, though not directly tied to explicit acceptance criteria:

Feature	Acceptance Criteria (Implied)	Reported Device Performance
Icterus Interference	No significant interference up to an I index of 60	No significant interference from bilirubin (conjugated or unconjugated) up to an I index of 60
Hemolysis Interference	(Not explicitly stated by the current document)	RBC contamination elevates results.
Lipemia Interference	No significant interference up to an L index of 1000	No significant interference from lipemia up to an L index of 1000
Specimen Collection	(Extended claims - details not provided in this excerpt)	Data described in Section VI (not provided in this excerpt)
Reportable Range (Urine)	(Extended claims - details not provided in this excerpt)	Data described in Section VI (not provided in this excerpt)
Imprecision	(Extended claims - details not provided in this excerpt)	Data described in Section VI (not provided in this excerpt)
Method Comparison (Urine)	(Extended claims - details not provided in this excerpt)	Data described in Section VI (not provided in this excerpt)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided text does not specify the sample size used for the test set for any of the performance characteristics or the data provenance (country of origin, retrospective/prospective nature). It only states that specific data on the performance of the system has been incorporated into the draft labeling in Section V and that data related to extended claims is described in Section VI. These sections are not included in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable to this type of in vitro diagnostic device (reagent for chemical analysis). Ground truth for chemical assays is typically established through reference methods and calibrated instruments, not expert human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable to this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., medical imaging, pathology).

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 information is not applicable to this type of in vitro diagnostic device. MRMC studies and concepts of human reader improvement with AI assistance are relevant to AI-based diagnostic tools that assist human interpreters (e.g., radiologists, pathologists). This device is a chemical reagent.

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

This information is not applicable in the context of an AI algorithm. For this chemical reagent, "standalone performance" refers to the performance of the reagent on an automated clinical chemistry analyzer without manual human intervention in the measurement process, which is inherent to its intended use with "automated clinical chemistry analyzers." However, the document does not explicitly detail the standalone performance study protocol or results beyond general statements about "performance characteristics."

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

For this type of chemical reagent, the ground truth for performance evaluation (e.g., accuracy, precision) would typically be established using:

Reference materials/calibrators: Samples with known, validated concentrations of inorganic phosphorus.
Reference methods: Established, highly accurate analytical methods considered the gold standard for measuring inorganic phosphorus.

The document does not explicitly state the type of ground truth used, but these are the standard practices for verifying the performance of such devices.

8. The sample size for the training set:

This information is not applicable because the device is a chemical reagent, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable as there is no "training set" for this chemical reagent.

Summary

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DEC 1 1998

510(k) Summary

Introduction

	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1) Submitter name, address, contact	Roche Diagnostics, Boehringer Mannheim Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000
	Contact Person: Jennifer Tribbett
	Date Prepared: September 25, 1998
2) Device name	Proprietary name: Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus Reagent
	Common name: Phosphorus (inorganic) test system
	Classification name: Phosphomolybdate (colorimetric), Inorganic Phosphorus, 75CEODevice Class I
3) Predicate device	We claim substantial equivalence to the currently marketed Roche Diagnostics, Boehringer Mannheim Phosphorus (inorganic) test system.
4) Device Description	Endpoint method with sample blanking.
	Inorganic phosphate forms an ammonium phosphomolybdate complex with ammonium molybdate in the presence of sulfuric acid. The complex is determined photometrically in the ultraviolet region (340 nm).

Continued on next page

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510(k) Summary, Continued

The Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus 5) Intended use Reagent is intended for the quantitative in vitro determination of phosphorus in human serum, plasma and urine with automated clinical chemistry analyzers.

The Roche Diagnostics, Boehringer Mannheim Phosphorus (inorganic) 6) Substantial equivalence -Reagent is substantially equivalent to other products in commercial Similarities distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics, Boehringer Mannheim Phosphorus (inorganic) reagent.

The following table illustrates the similarities between the Roche Diagnostics, Boehringer Mannheim Phosphorus (inorganic), extended claims reagent system and the currently marketed Phosphorus (inorganic) reagent system. Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission. The insert for the currently marketed phosphorus reagent is provided in Section VI .

Feature	Modified PhosphorusReagent Insert	Current PhosphorusReagent Insert
Intended Use	Measurement ofinorganic phosphorus	Same
Test Principle	Sample blank endpointmethod. Inorganicphosphate forms anammoniumphosphomolybdatecomplex withammonium molyddatein the presence ofsulfuric acid. Thecomplex is determinedphotometrically in theultraviolet region (340nm).	Same

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510(k) Summary, Continued

Limitations-Interferences	Icterus: No significantinterference frombilirubin (conjugated orunconjugated) up to anI index of 60Hemolysis: RBCcontamination elevatesresults.Lipemia (Intralipid):No significantinterference fromlipemia up to an Lindex of 1000	Same
	Kit Configuration,Reagent Preparation

Substantial equivalence – Similarities, continued

6) Substantial

equivalence differences

Differences:

The claims for specimen collection, reportable range (urine), imprecision and method comparison (urine) have been extended.

Performance characteristics:

The data related to these claims is decribed in section VI Based on the data, we believe that the extended claims continue to support substantial equivalence to other products in commercial distribution intended for similar use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 1998

Jennifer L. Tribbett Regulatory Affairs Consultant Boehringer Mannheim Corp. 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250

Re: K983503

Trade Name: Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Regulatory Class: I Product Code: CEO Dated: October 2, 1998 Received: October 6, 1998

Dear Ms. Tribbett:

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 legally marketed predicate 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 Regulations, 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 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 (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Autman

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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K983503 510(k) Number (if known): Device Name: Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus Reagent

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983503

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.