PHS reagent, in conjunction with SYNCHRON® Systems and SYNCHRON PTIS reagent, in ochjanoued for use in the quantitative determination of inorganic phosphorus in human serum, plasma, or urine.

Measurements of phosphorus (inorganic) are used in the diagnosis and incasuromento of in disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Device Description

The SYNCHRON Systems PHS reagent is designed for optimal performance on the CX (CX4CE/4/4PRO, CX5CE/52/5PRO, CX7/7RTS/7A/7PRO, SYNCHRON CX9ALX/9PRO) and LX (LX20/PRO/LXi 725) Systems. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that demonstrates the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the SYNCHRON® Systems Phosphorus (PHS) Reagent does not explicitly state pre-defined acceptance criteria with numerical targets (e.g., "Slope must be between 0.95 and 1.05"). Instead, it presents performance data (method comparison, linearity, and imprecision) and implies that these results demonstrate substantial equivalence to the predicate device.

However, based on the common practices for in vitro diagnostic (IVD) device submissions and the provided predicate comparison, we can infer the implied acceptance criteria:

Section	Implied Acceptance Criteria (Inferred)	Reported Device Performance and How it Meets Criteria
Method Comparison	The candidate device (SYNCHRON® Systems PHS Reagent) should show strong correlation and agreement with the predicate device (Beckman Coulter SYNCHRON PO4 Assay on CX Systems) when measuring inorganic phosphorus in human serum and urine. This is typically assessed by: - Slope: Close to 1.0 - Intercept: Close to 0.0 - R (Correlation Coefficient): Close to 1.0 (indicating a strong linear relationship)	Serum: - Slope: 0.997 (Very close to 1.0) - Intercept: -0.04 (Very close to 0.0) - R: 0.998 (Excellent linear correlation) Urine: - Slope: 0.976 (Close to 1.0) - Intercept: 0.25 (Reasonably close to 0.0) - R: 0.996 (Excellent linear correlation) Meets Criteria: The reported values for both serum and urine demonstrate excellent agreement and strong correlation with the predicate device, indicating substantial equivalence in measurement accuracy across relevant sample types.
Imprecision	The device should demonstrate acceptable within-run and total imprecision (reproducibility) for various concentrations of inorganic phosphorus in serum and urine. This is usually assessed by a low %CV (Coefficient of Variation) at different concentration levels. The acceptable %CV values would be determined by clinical relevance and comparison to the predicate or similar devices.	Within-Run Imprecision: - Serum 1 (2.0 mg/dL): 2.4 %C.V. - Serum 2 (6.6 mg/dL): 1.4 %C.V. - Urine 1 (41.1 mg/dL): 1.0 %C.V. - Urine 2 (78.3 mg/dL): 1.2 %C.V. Total Imprecision: - Serum 1 (2.0 mg/dL): 2.7 %C.V. - Serum 2 (6.6 mg/dL): 1.5 %C.V. - Urine 1 (41.1 mg/dL): 1.5 %C.V. - Urine 2 (78.3 mg/dL): 1.6 %C.V. Meets Criteria: The %C.V. values for both within-run and total imprecision are consistently low (all below 3%), indicating excellent precision and reproducibility across the tested concentrations and sample types. This is generally considered acceptable for clinical chemistry assays.
Linearity	The device should provide measurements that are linear across its claimed analytical measurement range. (While not explicitly detailed with data in the summary, linearity experiments are mentioned as being performed to demonstrate equivalence).	Reported: "Equivalence is demonstrated through method comparison, linearity, and imprecision experiments." Meets Criteria: The submission states that linearity experiments were performed and contributed to the finding of substantial equivalence. While specific data isn't provided, its inclusion in the summary implies acceptable results.

2. Sample Sizes Used for the Test Set and Data Provenance

Method Comparison Test Set:
- Serum: 114 samples (n=114)
- Urine: 81 samples (n=81)
Imprecision Test Set:
- For each of the 4 samples (Serum 1, Serum 2, Urine 1, Urine 2), the "N" value listed is 80. This typically refers to the number of replicates or data points used in the imprecision study.
Data Provenance: Not explicitly stated. For 510(k) submissions, data is typically generated internally by the manufacturer or by a contracted lab. The document does not specify the country of origin or if the data was retrospective or prospective. Given the nature of a reagent performance study, it's most likely prospective data collected specifically for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device (in vitro diagnostic reagent). For a phosphorus reagent, the "ground truth" is established by a reference method or a highly accurate clinical analyzer (in this case, the predicate device, Beckman Coulter SYNCHRON PO4 Assay on CX Systems). Expert consensus or human interpretation (like in imaging studies) is not used to establish the "ground truth" for quantitative chemical measurements.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used when human interpretation or expert opinion is involved in establishing a ground truth for qualitative or semi-quantitative results, particularly in areas like medical imaging. For a quantitative chemical assay, the comparison is directly between the candidate device's numerical output and the predicate device's numerical output.

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

No, an MRMC study was not done. This type of study is relevant for devices where human readers interpret diagnostic information (e.g., radiologists reading images) and the AI aims to assist or replace that human interpretation. The SYNCHRON PHS Reagent is an automated in vitro diagnostic assay where the output is a numerical value, not an interpretation by a human reader.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire performance summary (method comparison, linearity, and imprecision) is a demonstration of the SYNCHRON PHS Reagent's in vitro performance, independent of human interpretation or intervention beyond operating the analyzer. The results presented directly reflect the algorithm's (reagent's) ability to measure phosphorus.

7. Type of Ground Truth Used

The ground truth for the method comparison study was established by the predicate device, the Beckman Coulter SYNCHRON PO4 Assay on CX Systems. For imprecision studies, the ground truth is the "true" concentration of the sample, which is often determined through meticulous preparation of control materials or by a highly accurate reference method.

8. Sample Size for the Training Set

This information is not provided and is not typically relevant for a traditional chemical reagent assay like the SYNCHRON PHS Reagent. Chemical reagents are designed based on established chemical reactions and principles. They do not typically involve "training sets" in the machine learning sense. The performance data presented (method comparison, imprecision) serves as the validation of the reagent's performance.

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

As explained in point 8, a "training set" in the machine learning sense is not applicable here. The development of a chemical reagent involves chemical formulation, optimization of reaction conditions, and calibration using known reference materials. The "ground truth" for calibration and optimization would be highly characterized reference materials with known concentrations of inorganic phosphorus.

Summary

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K041643

AUG 1 8 2004

510(k) Summary SYNCHRON® Systems Phosphorus (PHS) Reagent

Submitted By: 1.0

Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123

2.0 Date Submitted:

June 15, 2004

Device Name(s): 3.0

Proprietary Names 3.1 SYNCHRON® Systems Phosphorus (PHS) Reagent

3.2 Classification Name Phosphorus (inorganic) test system (21 CFR § 862.1580)

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsPHS Reagent	SYNCHRON® SystemsPO4 Reagent	Beckman Coulter,Inc.*	K883181

*Beckman Coulter, Inc., Brea, CA

5.0 Description:

6.0 Intended Use:

PHS reagent, in conjunction with SYNCHRON Systems and SYNCHRON Multi Calibrator, is intended for use in the quantitative determination of inorganic phosphorus concentration in human serum, plasma, or urine.

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7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

	Similarities
PHS Reagent	Intended Use	Same as Beckman CoulterSYNCHRON CX Systems
	Methodology	PO4 Reagent
	Reactive Ingredients
	Sample Types
	Detection Wavelength
	Reaction Volumes (reagent, sample)
	Shelf Life
	Differences
	Reaction Type (endpoint)	PHS: Sample-blankedPO4: Reagent-blanked
	TCA precipitation method (for serumproteins)	PHS: CompatiblePO4: Incompatible
	Instrument Platforms:	PHS: CX CE/Δ/PRO Systems,LX20/PRO/LXi SystemsPO4: CX Systems only

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision experiments.

SYNCHRON CX Systems PHS Method Comparison Study Results

Candidate Method	SampleType	Slope	Intercept	R	n	Predicate Method
SYNCHRONSystems PHSReagent	Serum	0.997	-0.04	0.998	114	Beckman CoulterSYNCHRON PO4 Assayon CX Systems
	Urine	0.976	0.25	0.996	81

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Serum 1	2.0	0.05	2.4	80
Serum 2	6.6	0.09	1.4	80
Urine 1	41.1	0.43	1.0	80
Urine 2	78.3	0.91	1.2	80
Total Imprecision
Serum 1	2.0	0.05	2.7	80
Serum 2	6.6	0.10	1.5	80
Urine 1	41.1	0.61	1.5	80
Urine 2	78.3	1.26	1.6	80

SYNCHRON LX20 System PHS Estimated Imprecision

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 8 2004

Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc 200 South Kraemer Blvd. P.O. Box 8000 Brea, CA 92821

K041643 Re:

Korrollo
Trade/Device Name: SYNCHRON® Systems Phosphorus (PHS) Reagent Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) test system Regulatory Class: Class I Product Code: CEO Dated: June 15, 2004 Received: June 17, 2004

Dear Ms. Tang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four been wing the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic roll (110.) that 80 novice, subject to the general controls provisions of the Act. The r ou may, dicrorolo, mains of the Act include requirements for annual registration, listing of genoral controls provincitive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may be subject it bach adde of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that i Dri 3 localite over device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must or any it coord statutes and equirements, including, but not limited to: registration and listing (21 comply with and the right (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse FDA finding of substantial equivalence of your device to a legally prematication "Thesults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, if you destre spoorne miss and advertising of your device, please contact the Office of or Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outling of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K041643

Device Name:

SYNCHRON® Systems Phosphorus (PHS) Reagent

Indications for Use:

PHS reagent, in conjunction with SYNCHRON® Systems and SYNCHRON PTIS reagent, in ochjanoued for use in the quantitative determination of inorganic phosphorus in human serum, plasma, or urine.

Measurements of phosphorus (inorganic) are used in the diagnosis and incasuromonto of in disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

x Prescription Use (Part 21 CFR 801 Subpart D) Over-the-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041643

Page 1 of 1

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.