← Product Code [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO) · K041643

# SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643)

_Beckman Coulter, Inc. · CEO · Aug 18, 2004 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K041643

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO.md)
- **Decision Date:** Aug 18, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1580
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Indications for 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.

## Regulatory 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](/device/K883181.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE

A. 510(k) Number:
k041643

B. Purpose For Submission:
Premarket Notification 510(k) of intention to manufacture and market the Beckman Coulter SYNCHRON Systems Phosphorus Reagent.

C. Analyte:
Inorganic Phosphorus

D. Type of Test:
Quantitative

E. Applicant:
Beckman Coulter, Inc.

F. Proprietary and Established Names:
SYNCHRON® Systems Phosphorus (PHS) Reagent.

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1580, Phosphorous (inorganic) test_system.
2. Classification:
Class I
3. Product Code:
CEO
4. Panel:
75 Chemistry

H. Intended use(s):
1. Intended use(s)

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.

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2. **Indication(s) for 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.

3. **Special condition for use statement(s):**

For Prescription Use.

4. **Special instrument Requirements:**

The SYNCHRON Systems PHS Reagent is intended for use on the following models of SYNCHRON Systems: SYNCHRON LX®, LX PRO, LXi 725, CX®4CE, CX4 DELTA, CX4 PRO, CX5CE, CX5 DELTA, CX5 PRO, CX7, CX7 DELTA, CX7 RTS, CX7 PRO, CX9 ALX, and the CX9 PRO all of which have been previously cleared by the FDA 510(k) process. A summary of the 510(k) history for the instrumentation is provided in the table below:

|  System | FDA Docket #  |
| --- | --- |
|  SYNCHRON CX4CE | k904220  |
|  SYNCHRON CX7 | k904219  |
|  SYNCHRON CX7 RTS (Add to File) |   |
|  SYNCHRON CX5CE | k926060  |
|  SYNCHRON CX DELTA (CX4Δ, CX5Δ CX7Δ) | k950958  |
|  SYNCHRON CX9 ALX (Add to File |   |
|  SYNCHRON LX20 | k965240  |
|  SYNCHRON LX20 PRO | k011213  |
|  SYNCHRON CX PRO (CX4PRO, CX5PRO,CX7PRO,CX9PRO) | k011465  |
|  SYNCHRON LXi 725 | k023049  |

I. **Device Description:**

The SYNCHRON Systems PHS reagent is designed for optimal performance on the SYNCHRON CX (CX4CE/4Δ/4PRO, CX5CE/5Δ/4PRO CX7CE/7Δ/7PRO, CX9ALX/9PRO) AND LX (LX20/PRO/LXi 725) Systems. The ready to use liquid reagent kit contains two PHS 300 test cartridges. The cartridges are packaged separately from the associated calibrator.

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# J. Substantial Equivalence Information:

1. Predicate device name(s): Beckman Coulter Inc. SYNCHRON Systems PO4 Reagent.
2. Predicate k number(s): (k883181)
3. Comparison with Predicate:

Similarities between the Synchron Systems PHS Reagent and the predicate device are summarized below:

|  Reagent | Aspect / Characteristic | Comments  |
| --- | --- | --- |
|  Synchron Systems PHS Reagent | Intended Use | Same as Beckman Coulter's Synchron Systems PO4 Reagent  |
|   |  Methodology  |   |
|   |  Reactive Ingredients  |   |
|   |  Sample Types  |   |
|   |  Detection Wavelength  |   |
|   |  Reaction Volumes (sample, reagent)  |   |
|   |  Shelf Life  |   |

Differences between the candidate and predicate products are summarized below:

|  Reagent | Aspect / Characteristic | Comments  |
| --- | --- | --- |
|  Synchron Systems PHS Reagent | Non-reactive Ingredients | PHS: Optimized formulation
PO4: Original formulation  |
|   |  Reaction Type (endpoint) | PHS: Sample-blanked
PO4: Reagent-blanked  |
|   |  TCA precipitation method (for serum proteins) | PHS: Compatible
PO4: Incompatible  |
|   |  Instrument Platforms | PHS: CX CE / Δ / PRO and LX20 / PRO / LXi Systems
PO4: CX Systems Only  |

# K. Standard/Guidance Document Referenced (if applicable):

NCCLS EP5-A, NCCLS EP7-A, NCCLS GP16-T, NCCLS C28-A and FDA draft document "Replacement Reagent and Instrument Family Policy".

# L. Test Principle:

PHS reagent is used to measure the Phosphorus concentration by a timed endpoint method. In the reaction, inorganic phosphorus reacts with ammonium molybdate in an acid solution to form a colored phosphomolybdate complex.

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The SYNCHRON CX® System(s) automatically proportions the appropriate sample and reagent volumes into a cuvette. The ratio used is one part sample to 67 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is directly proportional to the concentration of phosphorus in the sample and is used by the system to calculate and express the Phosphorus concentration.

Chemical Reaction Scheme

$$
\mathrm {H} _ {2} \mathrm {S O} _ {4}
$$

Phosphorus + Molybdate  $\rightarrow$  Phosphomolybdate Complex

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Within-run and total precision studies were designed from NCCLS Guideline EP5-A. The Imprecision Evaluation Criteria (maximum performance limits) for the SYNCHRON Systems PHS Assay appears in the table below.

Imprecision Evaluation Criteria

|  Precision Measurement | Sample Type | S.D. (mg/dL) | % C.V. | Changeover Value (mg/dL)  |
| --- | --- | --- | --- | --- |
|  Within-Run Total | Serum/Plasma | 0.2 | 2.0 | 10.0  |
|   |   |  0.3 | 3.0 | 10.0  |
|  Within-Run Total | Urine | 2.0 | 2.0 | 100  |
|   |   |  3.0 | 3.0 | 100  |

Results of the within run and total precision evaluation for SYNCHRON CX and LX Systems are shown in the tables below. The user of a SYNCHRON System should expect the instrument to produce imprecision values less than or equal to the maximum performance limits. Multi-level control materials were used to demonstrate acceptable imprecision within the specifications selected for each sample type.

Precision Summary SYNCHRON CX Systems PHS

|  Sample | Mean (mg/dL) | S.D. (mg/dL) | % C.V. | N  |
| --- | --- | --- | --- | --- |
|  Within-Run Imprecision  |   |   |   |   |
|  Serum 1 | 1.9 | 0.04 | 2.2 | 80  |
|  Serum 2 | 6.4 | 0.08 | 1.3 | 80  |
|  Urine 1 | 40.0 | 0.54 | 1.4 | 80  |
|  Urine 2 | 76.6 | 1.03 | 1.3 | 80  |
|  Total Imprecision  |   |   |   |   |
|  Serum 1 | 1.9 | 0.05 | 2.6 | 80  |

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|  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  |
|  Serum 2 | 6.4 | 0.11 | 1.6 | 80  |
|  Urine 1 | 40.0 | 0.84 | 2.1 | 80  |
|  Urine 2 | 76.6 | 1.47 | 1.9 | 80  |

Precision Summary SYNCHRON LX System PHS

Precision

# b. Linearity/Assay reportable range:

Linearity (analytical range) studies were designed in accordance with NCCLS Guideline EP6-A. The study protocol utilized inter-dilutions of a patient specimen with a zero-level (saline) sample. To achieve an analyte concentration at the high end of the claimed analytical range, the patient specimen for each sample matrix was spiked with phosphate (diabasic). The recovered PHS values were plotted against the expected values an appropriate line fitted by standard linear regression. The table below summarizes the linearity studies.

|  SYNCHRON System | Sample Type | Measuring Range | Linear Regression Analysis | Assessment  |
| --- | --- | --- | --- | --- |
|  CX PRO | Serum/ Plasma | 1.0 – 12.0 mg/dL | Y = 1.012X – 0.02 | Linear  |
|  LX |   |   | Y = 1.016X – 0.08 | Linear  |
|  CX PRO | Urine | 10-120 mg/dL | Y = 1.030X – 1.69 | Linear  |
|  LX |   |   | Y = 0.995X + 0.28 | Linear  |

# c. Traceability (controls, calibrators, or method):

The SYNCHRON PHS Reagent is designed for use with the SYNCHRON MULTI Calibrator. SYNCHRON MULTI Calibrator (P/N 442600) is sold separate from the reagent kit. SYNCHRON MULTI Calibrator, used in conjunction with SYNCHRON

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REAGENTS, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Creatinine, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid. The calibrator is prepared from stabilized human serum and is traceable to serum reference material NIST 3139 through the value assignment process.

d. Detection limit:

The claimed sensitivity for inorganic phosphorus determination by the PHS assay is 1.0 mg/dL for serum and 10 mg/dL for urine. The analytical sensitivity of the PHS was evaluated by testing 20 replicates of saline (zero) and a patients sample diluted (with saline) to achieve a concentration less than the claimed sensitivity. Assay sensitivity is distinguishable with 95% confidence if the mean recovery from the sensitivity sample minus two standard deviations is greater than the corresponding mean from the zero sample plus two standard deviations. The results are shown in the tables below.

Serum Analytical Sensitivity Study SYNCHRON Systems PHS

|  Rep | CX (mg/dL) |   |   | LX (mg/dL)  |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  Saline | Sample 1 | Sample 2 | Saline | Sample 1 | Sample 2  |
|  1 | -0.02 | 0.85 | 0.69 | 0.00 | 0.88 | 0.71  |
|  2 | -0.01 | 0.82 | 0.75 | 0.00 | 0.88 | 0.71  |
|  3 | 0.00 | 0.85 | 0.72 | 0.00 | 0.87 | 0.72  |
|  4 | 0.00 | 0.87 | 0.71 | 0.00 | 0.87 | 0.70  |
|  5 | -0.01 | 0.85 | 0.69 | 0.00 | 0.87 | 0.74  |
|  6 | 0.00 | 0.86 | 0.70 | 0.01 | 0.86 | 0.67  |
|  7 | -0.02 | 0.85 | 0.70 | 0.00 | 0.89 | 0.69  |
|  8 | -0.01 | 0.82 | 0.71 | 0.00 | 0.86 | 0.73  |
|  9 | 0.00 | 0.87 | 0.70 | 0.00 | 0.87 | 0.71  |
|  10 | 0.00 | 0.88 | 0.69 | 0.00 | 0.87 | 0.68  |
|  11 | 0.03 | 0.87 | 0.72 | 0.00 | 0.86 | 0.72  |
|  12 | 0.00 | 0.89 | 0.70 | 0.00 | 0.87 | 0.73  |
|  13 | -0.01 | 0.87 | 0.69 | 0.00 | 0.88 | 0.71  |
|  14 | -0.01 | 0.87 | 0.70 | 0.00 | 0.89 | 0.71  |
|  15 | -0.01 | 0.86 | 0.70 | 0.00 | 0.88 | 0.73  |
|  16 | 0.02 | 0.85 | 0.69 | 0.00 | 0.87 | 0.73  |
|  17 | 0.01 | 0.87 | 0.72 | 0.01 | 0.88 | 0.68  |
|  18 | 0.00 | 0.83 | 0.72 | 0.00 | 0.87 | 0.69  |
|  19 | 0.00 | 0.87 | 0.70 | 0.00 | 0.88 | 0.73  |
|  20 | 0.01 | 0.85 | 0.71 | 0.00 | 0.90 | 0.71  |
|  |   |   |   |   |   |   |

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|  average | 0.00 | 0.86 | 0.71 | 0.00 | 0.88 | 0.71  |
| --- | --- | --- | --- | --- | --- | --- |
|  Sd | 0.01 | 0.02 | 0.01 | 0.00 | 0.01 | 0.02  |
|  min | -0.02 | 0.82 | 0.69 | 0.00 | 0.86 | 0.67  |
|  max | 0.03 | 0.89 | 0.75 | 0.01 | 0.90 | 0.74  |
|  2 SD Limits | 0.02 | 0.82 | 0.68 | 0.00 | 0.85 | 0.67  |
|   | Pass |   |   | Pass  |   |   |

Urine Analytical Sensitivity Study SYNCHRON Systems PHS

|  Rep | CX (mg/dL) |   |   | LX (mg/dL)  |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  Saline | Sample 1 | Sample 2 | Saline | Sample 1 | Sample 2  |
|  1 | 0.00 | 7.6 | 6.4 | 0.0 | 7.8 | 6.1  |
|  2 | 0.00 | 7.8 | 6.5 | 0.0 | 7.6 | 6.4  |
|  3 | -0.01 | 7.7 | 6.5 | 0.0 | 7.6 | 6.3  |
|  4 | 0.1 | 7.8 | 6.5 | 0.0 | 7.4 | 7.1  |
|  5 | 0.0 | 7.9 | 6.4 | 0.0 | 7.8 | 6.8  |
|  6 | 0.1 | 7.8 | 6.8 | 0.1 | 7.2 | 6.1  |
|  7 | 0.0 | 7.7 | 6.6 | 0.0 | 8.0 | 6.4  |
|  8 | 0.0 | 7.8 | 6.6 | 0.0 | 8.3 | 6.8  |
|  9 | 0.1 | 7.6 | 6.7 | 0.0 | 7.8 | 6.5  |
|  10 | 0.1 | 7.9 | 6.6 | 0.1 | 7.8 | 6.2  |
|  11 | 0.1 | 7.8 | 6.6 | 0.2 | 7.8 | 6.5  |
|  12 | 0.0 | 7.9 | 6.5 | 0.1 | 7.8 | 5.9  |
|  13 | 0.1 | 7.8 | 6.5 | 0.0 | 8.0 | 6.9  |
|  14 | 0.1 | 7.7 | 6.7 | 0.1 | 7.3 | 6.5  |
|  15 | 0.3 | 7.8 | 6.5 | 0.0 | 7.9 | 6.7  |
|  16 | 0.1 | 8.0 | 6.7 | 0.0 | 7.3 | 6.5  |
|  17 | 0.0 | 7.8 | 6.8 | 0.0 | 7.8 | 6.1  |
|  18 | 0.0 | 8.1 | 6.9 | 0.3 | 7.5 | 6.4  |
|  19 | 0.1 | 7.9 | 6.4 | 0.0 | 8.3 | 6.4  |
|  20 | 0.3 | 8.1 | 6.8 | 0.3 | 8.1 | 6.4  |
|  average | 0.07 | 7.83 | 6.60 | 0.06 | 7.76 | 6.45  |
|  Sd | 0.10 | 0.14 | 0.15 | 0.10 | 0.31 | 0.30  |
|  min | -0.10 | 7.60 | 6.40 | 0.00 | 7.20 | 5.90  |
|  max | 0.30 | 8.10 | 6.90 | 0.30 | 8.30 | 7.10  |
|  2 SD Limits | 0.27 | 7.55 | 6.30 | 0.26 | 7.13 | 5.85  |
|   | Pass |   |   | Pass  |   |   |

# e. Analytical specificity:

Interference studies were performed on the PHS Reagent to assess common or known substances that could interfere with the method. Interference studies were designed in accordance with NCCLS Guideline EP7-A. A substance was considered to show no significant

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interference if the test sample was within  $0.4\mathrm{mg / dL}$  or  $4 \%$  of the control specimen recovery. The detailed test results are summarized in the table below.

|  Substance | Source | Level Tested | Observed Effecta  |
| --- | --- | --- | --- |
|  Hemoglobin | RBC Hemolysate | 250 mg/dL | NSIb +0.5 mg/dL  |
|  Bilirubin | Porcine | 375 mg/dL | NSI  |
|  Lipemia | Human | 30 mg/dL | NSI  |
|  Methotrexate | NAc | 4+ (visual) | NSI  |
|  Cefotaxime | Sodium salt | 2.0 mmol/L | NSI  |
|  Ascorbic Acid | L-Ascorbic Acid | 50 mg/dL | NSI  |
|  Fluorescein | Disodium salt | 20 mg/dL | +0.7 mg/dL  |
|  Nafcillin | NA | 75 mg/dL | NSI +0.7 mg/dL  |
|  Methylbenzethonium Chloride | NA | 5 mg/dL | NSI  |
|  Rifampin | NA | 10 mg/dL | NSI  |

a Plus (+) or minus (-) signs in this column signify positive or negative interference.
b NSI = No Significant Interference within ± 0.4 mg/dL or 4%
$^{\mathrm{c}}$  NA = Not applicable

# f. Assay cut-off: Not applicable

# 2. Comparison studies:

# a. Method comparison with predicate device:

Method comparison experiments were designed using NCCLS Procedure EP9-A, and employed Deming regression analysis to assess the data. The patient correlation studies were obtained using the Beckman Coulter SYNCHRON CX PO4 Assay and the candidate PHS Reagent on representative CX and LX Systems. Patient specimen phosphorus concentrations spanned the analytical range for both sample types.

The tables below summarize the results of the methods comparison studies. The Deming regression analysis demonstrates comparable performance across the analytical range for each sample type between SYNCHRON PHS Reagent and the predicate method.

Serum Method Comparison Summary

|  Candidate | Platform | Slope | Intercept | r | n | Predicate Method  |
| --- | --- | --- | --- | --- | --- | --- |
|  PHS Reagent | CX | 0.997 | -0.04 | 0.998 | 114 | Beckman Coulter SYNCHRON CX Systems PO4 Assay  |
|   |  LX | 0.984 | 0.12 | 0.999 | 112  |   |
|   | LX | 0.997 | 0.12 | 0.999 | 112 |   |

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# Urine Method Comparison Summary

|  Candidate | Platform | Slope | Intercept | r | n | Predicate Method  |
| --- | --- | --- | --- | --- | --- | --- |
|  PHS Reagent | CX | 0.976 | 0.25 | 0.996 | 81 | Beckman Coulter SYNCHRON CX Systems PO4 Assay  |
|   |  LX | 1.041 | -0.62 | 0.995 | 78  |   |

*b. Matrix comparison:*

Serums versus plasma studies were performed to substantiate the use of EDTA and heparin anticoagulants for phosphorus testing. For each anticoagulant, health volunteers were drawn. Some specimens were spiked with inorganic phosphorus to more adequately cover the claimed performance range. Paired samples (serum and plasma) were analyzed by the PHS assay on both CX and LX Systems. Random sampling of at least 40 patient specimens was analyzed on each platform. Deming regression analysis was used to evaluate the results.

|  System | Anticoagulant | Level of Anticoagulant Tested | Deming Regression Analysis  |
| --- | --- | --- | --- |
|  SYNCHRON CX | EDTA | 1.5 mg/mL | Y = 0.952X-0.11
r² = 0.998  |
|   |  Lithium Heparin | 14 units/mL | Y = 1.026X-0.19
r² = 0.999  |
|   |  Sodium Heparin | 14 units/mL | Y = 1.024X-0.23
r² = 0.999  |
|  SYNCHRON LX | EDTA | 1.5 mg/mL | Y = 0.919X+0.01
r² = 0.997  |
|   |  Lithium Heparin | 14 units/mL | Y = 1.004X-0.09
r² = 0.998  |
|   |  Sodium Heparin | 14 units/mL | Y = 1.002X-0.07
r² = 0.999  |

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable): N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range:

The reference interval for the SYNCHRON Systems PHS assay is taken from the predicate insert. Beckman Coulter performed confirmatory studies with the PHS

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reagent on CX and LX Systems to verify the claimed reference interval. These confirmatory studies were designed in accordance with NCCLS Guideline C28-A.

Serum samples were drawn from a population of 60 apparently health, non smoking male and female adults (>18 years of age) from Southern California over a three day period. All samples were analyzed in duplicate by the SYNCHRON Systems. A random sampling of 20 subjects was used for the analysis. Acceptance criteria required at least 90% of the sample set to have PHS reported values within the cited reference interval. The results of these studies are consistent with the reference intervals in the reporting results section of the SYNCHRON Systems PHS Reagent Chemistry Information Sheet, and summarized in the chart below.

|  INTERVALS | SAMPLE TYPE | CONVENTIAL UNITS | S.I. UNITS  |
| --- | --- | --- | --- |
|  SYNCHRON Systems | Serum or Plasma | 2.5 – 4.6 mg/dL | 0.81 – 1.49 mmol/L  |
|  Literature^{5} | Urine (non-restricted diet) | 0.4 – 1.3 g/24 hrs | 129 -420 mmol/24 hrs  |

The labeling recommends that each laboratory should establish its own reference intervals based upon its patient population. The reference intervals listed above were taken from the described study performed on SYNCHRON Systems.

5. Tietz, N.W., Clinical Guide to Laboratory Tests, 2nd Edition, W.B. Saunders, Philadelphia, PA (1990).

## N. Conclusion:

The submitted material in this premarket notification is complete and supports a substantial equivalence decision.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K041643](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K041643)

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