SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT

K041643 · Beckman Coulter, Inc. · CEO · Aug 18, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041643
• Device Name: SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: CEO · Clinical Chemistry
• Decision Date: Aug 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

The SYNCHRON® Systems Phosphorous (PHS) Reagent, in conjunction with SYNCHRON® Multi Calibrator, is intended for use in the quantitative determination of inorganic phosphorous in human serum, plasma, or urine. Measurements of phosphorous (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Device Story

SYNCHRON Systems PHS Reagent is an in vitro diagnostic reagent for quantitative measurement of inorganic phosphorus in human serum, plasma, or urine. Used on Beckman Coulter CX and LX clinical chemistry analyzer platforms; operated by laboratory professionals. Reagent kit contains two 300-test cartridges. Principle of operation involves chemical reaction with sample; analyzer performs photometric measurement. Output is phosphorus concentration value (mg/dL). Results assist clinicians in diagnosing and monitoring metabolic disorders related to parathyroid function, renal health, and vitamin D status.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A; linearity per EP6-A; interference per EP7-A. Method comparison (Deming regression) against predicate performed on CX and LX platforms (n=78-114 per group, r > 0.99). Reference interval verification performed per NCCLS C28-A on 60 healthy adults.

Technological Characteristics

Liquid reagent kit containing ammonium molybdate in acid solution. Timed endpoint spectrophotometric detection at 340 nm. Compatible with SYNCHRON CX and LX automated chemistry analyzers. Traceable to NIST 3139 via SYNCHRON Multi Calibrator. Standards referenced: NCCLS EP5-A, EP7-A, GP16-T, C28-A.

Indications for Use

Indicated for quantitative determination of inorganic phosphorus in human serum, plasma, or urine. Used in diagnosis and monitoring 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

• SYNCHRON® Systems PO4 Reagent (K883181)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

#### 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 | Docket<br>Number |
|----------------------------------|----------------------------------|---------------------------|------------------|
| SYNCHRON® Systems<br>PHS Reagent | SYNCHRON® Systems<br>PO4 Reagent | Beckman Coulter,<br>Inc.* | K883181 |

*Beckman Coulter, Inc., Brea, CA

### 5.0 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.

### 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 Coulter<br>SYNCHRON CX Systems |
| | Methodology | PO4 Reagent |
| | Reactive Ingredients | |
| | Sample Types | |
| | Detection Wavelength | |
| | Reaction Volumes (reagent, sample) | |
| | Shelf Life | |
| | Differences | |
| | Reaction Type (endpoint) | PHS: Sample-blanked<br>PO4: Reagent-blanked |
| | TCA precipitation method (for serum<br>proteins) | PHS: Compatible<br>PO4: Incompatible |
| | Instrument Platforms: | PHS: CX CE/Δ/PRO Systems,<br>LX20/PRO/LXi Systems<br>PO4: 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 | Sample<br>Type | Slope | Intercept | R | n | Predicate Method |
|------------------------------------|----------------|-------|-----------|-------|-----|--------------------------------------------------------|
| SYNCHRON<br>Systems PHS<br>Reagent | Serum | 0.997 | -0.04 | 0.998 | 114 | Beckman Coulter<br>SYNCHRON PO4 Assay<br>on 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

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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 [phone]. 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 [phone] or [phone] 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

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