← Product Code [CIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX) · K110818

# POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS (K110818)

_Polymedco, Inc. · CIX · Sep 8, 2011 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K110818

## Device Facts

- **Applicant:** Polymedco, Inc.
- **Product Code:** [CIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX.md)
- **Decision Date:** Sep 8, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1035
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the Poly-Chem 90 analyzer. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to measure the total calcium level in human serum on the Poly-Chem 90 analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90 analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

## Device Story

Poly-Chem 90 test system consists of reagents for measuring albumin, BUN, calcium, carbon dioxide, and creatinine in human serum; intended for use on the Poly-Chem 90 analyzer. Device functions as an in vitro diagnostic tool in clinical laboratory settings. Analyte concentrations are measured via chemical reaction on the analyzer; results are provided to clinicians to aid in diagnosis and management of renal, hepatic, metabolic, and bone-related diseases. System provides quantitative data to support clinical decision-making regarding patient metabolic status and organ function.

## Clinical Evidence

Bench testing only. Performance validated via precision (intra-assay and inter-assay), linearity, limit of detection (LoB/LoD/LoQ), and endogenous interference studies (hemoglobin, bilirubin, triglyceride). Method comparison performed against predicate Poly-Chem 180 analyzer using 43-50 patient serum samples per analyte; Passing-Bablok regression showed high correlation (r > 0.99) and slopes near 1.0.

## Technological Characteristics

Quantitative photometric assays. Reagents include buffers, enzymes (urease, GLDH, PEPC, MDH), and chromogens (bromocresol green, O-cresolphthalein complexone, picric acid). Analyzed on Poly-Chem 90 instrument. Traceable to NIST/DA470 reference materials. Complies with CLSI EP5-A2, EP6-A, and EP17-A guidelines.

## Regulatory Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

## Submission Summary (Full Text)

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

A. 510(k) Number:
k110818

B. Purpose for Submission:
New device

C. Measurand:
Albumin, BUN, Calcium, Carbon Dioxide, Creatinine

D. Type of Test:
Quantitative, Photometry

E. Applicant:
Polymedco, Inc.

F. Proprietary and Established Names:
Poly-Chem 90 Albumin, Poly-Chem 90 BUN, Poly-Chem 90 Calcium, Poly-Chem 90 Carbon Dioxide, Poly-Chem 90 Creatinine

G. Regulatory Information:

|  Product Code | Name and Regulation Section | Class | Panel  |
| --- | --- | --- | --- |
|  CIX | Albumin test system 21 CFR 862.1035 | II | 75 Clinical Chemistry  |
|  CDQ | Urea Nitrogen test system 21 CFR 862.1770 | II | 75 Clinical Chemistry  |
|  CIC | Calcium test system 21 CFR 862.1145 | II | 75 Clinical Chemistry  |
|  KHS | Bicarbonate/carbon dioxide test system 21 CFR 862.1160 | II | 75 Clinical Chemistry  |
|  CGX | Creatinine Test System 21 CFR 862.1225 | II | 75 Clinical Chemistry  |

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H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end product of nitrogen metabolism) in human serum on the Poly-Chem 90 analyzer. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to measure the total calcium level in human serum on the Poly-Chem 90 analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90 analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

3. Special conditions for use statement(s):

For prescription use only.

4. Special instrument requirements:

Poly-Chem 90 Analyzer (k090703)

I. Device Description:

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Albumin consists of the following in vitro diagnostic reagents: Succinate buffer; pH 4.2, Bromocresol green, Brij 35 and methylisothiazolon as a preservative.

BUN consists of the following in vitro diagnostic reagents: R1-Coenzyme, Capso Buffer, pH 9.65 and NADH. R2-Enzymes/Substrate, Bicine Buffer, Urease, GLDH and α-oxoglutarate.

Calcium consists of the following in vitro diagnostic reagents: R1-Buffer, Ethanolamine Buffer. R2-Chromogen, O-Cresolphthalein complexone, 8-Hydroxyquinoline and Hydrochloric Acid.

Carbon Dioxide consists of the following in vitro diagnostic reagents: Phosphoenolpyruvate (PEP), NADH analog, Phosphoenolpyruvate Carboxylase (PEPC), and Malate Dehydrogenase (MDH)

Creatinine consists of an R1 and an R2 reagent. R1 reagent contains Sodium Hydroxide, R2 reagent contains Picric Acid.

## J. Substantial Equivalence Information:

1. Predicate device name(s)

Poly-Chem Albumin, Poly-Chem BUN, Poly-Chem Calcium, Poly-Chem Carbon Dioxide, and Poly-Chem Creatinine

2. Predicate 510(k) number(s)

k020852, previously cleared as: Randox Albumin (k984494), Randox BUN (k923506), Randox Calcium (k000375), Randox Carbon Dioxide (k951221), Randox Creatinine (k973993)

3. Comparison with predicate:

|  Similarities and Differences Albumin  |   |   |
| --- | --- | --- |
|  Item | Device
Poly-Chem 90 Albumin | Predicate
Poly-Chem Albumin  |
|  Intended Use | For the quantitative in vitro determination of Albumin in serum. | Same  |
|  Sample Type | Serum | Serum and Plasma  |
|  Measuring range | 0.2 – 5.0 mg/dL | 0.47 – 5.0 mg/dL  |
|  Storage/stability | Stable until expiration date when stored at 15-25°C. On-board stability is 30 days at 10°C. | Same  |
|  Analyzer | Poly-Chem 90 | Poly-Chem 180  |

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|  Similarities and Differences BUN  |   |   |
| --- | --- | --- |
|  Item | DevicePoly-Chem 90 BUN | PredicatePoly-Chem BUN  |
|  Intended Use | For the quantitative in vitro determination of blood urea nitrogen in serum | Same  |
|  Sample Type | Serum | Serum, plasma, urine  |
|  Measuring Range | 5.5 – 160.1 mg/dL | 4.1 - 142 mg/dL  |
|  Storage/stability | R1 reagent - Stable until expiration date when stored at 2-8°C. Once opened reagent is stable for 30 days on board the analyzer at 10°C.R2 reagent- Stable until expiration date when stored at 2-8°C. Once opened the reagent is stable for 28 days on board the analyzer at 10°C. | Same  |
|  Analyzer | Poly-Chem 90 | Poly-Chem 180  |
|  Similarities and Differences Calcium  |   |   |
| --- | --- | --- |
|  Item | DevicePoly-Chem 90 Calcium | PredicatePoly-Chem Calcium  |
|  Intended Use | For the quantitative in vitro determination of the total Calcium in serum. | Same  |
|  Sample Type | Serum | Serum and Urine  |
|  Measuring Range | 0.7 – 20.0 mg/dL | 0.76 – 20.04 mg/dL  |
|  Storage/Stability | Stable until expiration when stored at 15 - 25°C. Once opened the reagent is stable for 28 days on board the instrument at 10°C. | Same  |
|  Analyzer | Poly-Chem 90 | Poly-Chem 180  |

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|  Similarities and Differences Carbon Dioxide  |   |   |
| --- | --- | --- |
|  Item | Device
Poly-Chem 90 Carbon Dioxide | Predicate
Poly-Chem Carbon Dioxide  |
|  Intended Use | For the quantitative in vitro determination of Carbon Dioxide in serum. | Same  |
|  Sample Type | Serum | Serum and Plasma  |
|  Measuring Range | 5-49 mmol/L | 2.9 – 50 mmol/L  |
|  Storage/Stability | Stable until expiration date on the label when unopened and stored at 2-8°C. | Same  |
|  Analyzer | Poly-Chem 90 | Poly-Chem 180  |
|  Similarities and Differences Creatinine  |   |   |
| --- | --- | --- |
|  Item | Device
Poly-Chem 90 Creatinine | Predicate
Poly-Chem Creatinine  |
|  Intended Use | For the quantitative in vitro determination of Creatinine in serum. | Same  |
|  Sample Type | Serum | Serum and urine  |
|  Measuring Range | 0.3 – 20.7 mg/dL | 0.31 – 22 mg/dL  |
|  Storage/Stability | R1 and R2 Reagents- Stable until expiration date on label when stored at 15-25°C. Once opened the reagent should be capped and stored in the refrigerator at 2-8°C overnight or when not in use. On-board stability is 3 days at 10°C. | Same  |
|  Analyzer | Poly-Chem 90 | Poly-Chem 180  |

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

CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods;

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Approved Guideline-Second Edition

CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Statistical Approach: Approved Guideline

CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline

L. Test Principle:

Albumin: The measurement of serum albumin is based on its quantitative binding to the indicator 3,3',5,5'-tetrabromo-mcresol sulphonphtalein (bromocresol green). The albumin-BCG-complex absorbs maximally at 578 nm.

BUN: The measurement of BUN in serum is based on the hydrolysis of urea in the presence of water and urease to produce ammonia and carbon dioxide. The ammonia produced in the first reaction combines with α-oxoglutarate and NADH in the presence of glutamate-dehydrogenase to yield glutamate and NAD⁺.

Calcium: The measurement of calcium in serum is based on calcium ions forming a violet complex with O-cresolphthalein complexone in an alkaline medium

Carbon Dioxide: The measurement of carbon dioxide in serum is an enzymatic procedure employing phosphoenolpyruvate carboxylase (PEPC) and a stabilized NADH analog. PEPC catalyzes the first reaction which produces oxaloacetate. In the presence of MDH, the reduced cofactor is oxidized by oxaloacetate. The decrease in concentration of the reduced cofactor is monitored between 405 and 415 nm and is proportional to the total carbon dioxide concentration in the sample.

Creatinine: The measurement of creatinine in serum is based on creatinine in an alkaline solution reacting with picrate to form a colored complex. The rate of formation of the complex is measured.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision studies were performed at three levels of each test on two separate Poly-Chem 90 analyzers over 10 days. Samples were tested in duplicate twice a day (n=80) for each level tested for each analyte. Results for inter-assay precision are summarized in the tables below.

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|   |   |   | Within run |   | Between run  |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Albumin Sample | Instrument | Mean (mg/dl) | SD | %CV | SD | %CV  |
|  1 | 1 | 1.46 | 0.025 | 1.68 | 0.037 | 2.52  |
|   |  2 | 1.47 | 0.016 | 1.11 | 0.036 | 2.48  |
|  2 | 1 | 2.86 | 0.035 | 1.22 | 0.060 | 2.09  |
|   |  2 | 2.88 | 0.018 | 0.63 | 0.062 | 2.15  |
|  3 | 1 | 4.66 | 0.076 | 1.63 | 0.099 | 2.12  |
|   |  2 | 4.71 | 0.022 | 0.47 | 0.083 | 1.76  |
|   |   |   | Within run |   | Between run  |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Bun Sample | Instrument | Mean (mg/dl) | SD | %CV | SD | %CV  |
|  1 | 1 | 16.6 | 0.66 | 4.0 | 0.88 | 5.3  |
|   |  2 | 16.7 | 0.33 | 2.0 | 0.45 | 2.7  |
|  2 | 1 | 52.4 | 0.85 | 1.6 | 1.01 | 1.9  |
|   |  2 | 51.7 | 0.53 | 1.0 | 0.80 | 1.6  |
|  3 | 1 | 112.1 | 0.76 | 0.7 | 1.27 | 1.1  |
|   |  2 | 110.0 | 0.64 | 0.6 | 1.87 | 1.7  |
|   |   |   | Within run |   | Between run  |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Calcium Sample | Instrument | Mean (mg/dl) | SD | %CV | SD | %CV  |
|  1 | 1 | 4.07 | 0.155 | 3.81 | 0.251 | 6.18  |
|   |  2 | 4.11 | 0.138 | 3.36 | 0.201 | 4.90  |
|  2 | 1 | 8.55 | 0.198 | 2.32 | 0.286 | 3.35  |
|   |  2 | 8.56 | 0.137 | 1.60 | 0.214 | 2.51  |
|  3 | 1 | 15.01 | 0.122 | 0.82 | 0.366 | 2.44  |
|   |  2 | 15.07 | 0.136 | 0.90 | 0.351 | 2.33  |

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|   |   |   | Within run |   | Between run  |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Carbon Dioxide Sample | Instrument | Mean (mmol/l) | SD | %CV | SD | %CV  |
|  1 | 1 | 8.7 | 0.42 | 4.8 | 0.80 | 9.2  |
|   |  2 | 8.8 | 0.27 | 3.1 | 0.77 | 8.7  |
|  2 | 1 | 18.6 | 0.39 | 2.1 | 0.83 | 4.5  |
|   |  2 | 18.7 | 0.50 | 2.7 | 0.86 | 4.6  |
|  3 | 1 | 42.0 | 0.61 | 1.46 | 2.71 | 6.4  |
|   |  2 | 42.6 | 0.35 | 0.83 | 2.27 | 5.3  |
|   |   |   | Within run |   | Between run  |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Creatinine Sample | Instrument | Mean (mg/dl) | SD | %CV | SD | %CV  |
|  1 | 1 | 0.65 | 0.022 | 3.40 | 0.033 | 4.99  |
|   |  2 | 0.65 | 0.016 | 2.44 | 0.045 | 6.93  |
|  2 | 1 | 1.35 | 0.025 | 1.83 | 0.035 | 2.60  |
|   |  2 | 1.30 | 0.026 | 2.00 | 0.046 | 3.57  |
|  3 | 1 | 3.80 | 0.040 | 1.06 | 0.084 | 2.22  |
|   |  2 | 3.86 | 0.041 | 1.07 | 0.067 | 1.75  |
|  4 | 1 | 15.14 | 0.103 | 0.68 | 0.372 | 2.46  |
|   |  2 | 15.54 | 0.091 | 0.58 | 0.291 | 1.88  |

Intra-assay precision was performed with three serum samples at different concentrations of the analyte on two Poly-Chem 90 analyzers. Twenty replicates of each sample were tested within one instrument run. Results are summarized in the table below:

|  Albumin Replicate | Level 1 |   | Level 2 |   | Level 3  |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2  |
|  Mean (mg/dL) | 1.46 | 1.48 | 2.86 | 2.91 | 4.61 | 4.72  |
|  SD | 0.043 | 0.010 | 0.045 | 0.012 | 0.050 | 0.032  |
|  %CV | 2.9 | 0.7 | 1.6 | 0.4 | 1.1 | 0.7  |
|  Minimum | 1.42 | 1.46 | 2.74 | 2.90 | 4.47 | 4.67  |
|  Maximum | 1.63 | 1.49 | 2.92 | 2.94 | 4.67 | 4.78  |
|  Range | 0.21 | 0.03 | 0.18 | 0.04 | 0.20 | 0.11  |

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|  BUN Replicate | Level 1 |   | Level 2 |   | Level 3  |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2  |
|  Mean (mg/dL) | 16.8 | 16.9 | 52.0 | 52.0 | 109.2 | 110.5  |
|  SD | 0.90 | 0.36 | 1.27 | 0.48 | 1.56 | 0.81  |
|  %CV | 5.3 | 2.1 | 2.5 | 0.9 | 1.4 | 0.7  |
|  Minimum | 15.3 | 16.2 | 49.5 | 51.3 | 104.9 | 108.4  |
|  Maximum | 18.5 | 18.0 | 54.3 | 52.8 | 111.7 | 111.7  |
|  Range | 3.2 | 1.8 | 4.8 | 1.5 | 6.8 | 3.3  |
|  Calcium Replicate | Level 1 |   | Level 2 |   | Level 3  |   |
|   |  INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2  |
|  Mean (mg/dL) | 4.3 | 4.3 | 8.8 | 8.8 | 15.1 | 15.3  |
|  SD | 0.08 | 0.08 | 0.03 | 0.05 | 0.24 | 0.18  |
|  %CV | 1.8 | 1.9 | 0.3 | 0.5 | 1.6 | 1.2  |
|  Minimum | 4.2 | 4.1 | 8.8 | 8.7 | 14.6 | 15.0  |
|  Maximum | 4.4 | 4.4 | 8.9 | 8.9 | 15.4 | 15.5  |
|  Range | 0.2 | 0.3 | 0.1 | 0.2 | 0.8 | 0.5  |
|  Carbon Dioxide | Level 1 |   | Level 2 |   | Level 3  |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2  |
|  Replicate | 1 | 2 | 1 |  | 1 | 2  |
|  Mean (mg/dL) | 9 | 9 | 19 | 19 | 44 | 43  |
|  SD | 0.6 | 0.4 | 0.2 | 0.4 | 0.7 | 0.8  |
|  %CV | 6.8 | 4.0 | 1.2 | 1.9 | 1.6 | 1.9  |
|  Minimum | 8 | 9 | 19 | 18 | 43 | 41  |
|  Maximum | 10 | 10 | 20 | 19 | 45 | 44  |
|  Range | 2 | 1 | 1 | 1 | 2 | 3  |
|  Creatinine Replicate | Level 1 |   | Level 2 |   | Level 3  |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2 | INSTR 1 | INSTR 2  |
|  Mean (mg/dL) | 0.64 | 0.65 | 3.67 | 3.83 | 15.09 | 15.59  |
|  SD | 0.024 | 0.031 | 0.028 | 0.036 | 0.101 | 0.105  |
|  %CV | 3.7 | 4.8 | 0.8 | 0.9 | 0.7 | 0.7  |
|  Minimum | 0.59 | 0.60 | 3.63 | 3.77 | 14.92 | 15.41  |

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b. Linearity/assay reportable range:

The linearity of each analyte on the Poly-Chem 90 system was tested by mixing human serum containing the analyte to several levels of the test to obtain 7 concentration levels for each analyte (Albumin 0.17-6.67 g/dL; BUN 5.4-160.1 mg/dL; Calcium 0.7-20.1 mg/dL; Carbon Dioxide 5-49 mmol/L; Creatinine 0.3-20.7 mg/dL). Recoveries ranged from 91.3 to 108.0% for Albumin; 96.7-100% for BUN; 93.7-101.3% for Calcium; 100-101.4% for Carbon Dioxide and from 96.5-100% for Creatinine. The summary of linear regression analysis of data is given in the table below.

|  Test | Range Tested | Slope (95% CI) | Intercept (95% CI)  |
| --- | --- | --- | --- |
|  Albumin | 0.2 – 6.7 g/dL | 0.90
(0.87-0.93) | 0.20
(0.08 – 0.31)  |
|  BUN | 5.4 – 160.1 mg/dL | 1.01
(1.00- 1.01) | -0.27
(-0.75 – 0.21)  |
|  Calcium | 0.7-20.1 mg/dL | 1.03
(1.02-1.04) | -0.24
(-0.36 - -0.13)  |
|  Carbon Dioxide | 5.0 – 49.0 mmol/L | 1.02
(0.99-1.05) | 0.37
(-0.50 – 1.23)  |
|  Creatinine | 0.3-20.7 mg/dL | 1.00
(1.00 – 1.01) | 0.04
(-0.03 – 0.11)  |

The linearity studies support the sponsor's claimed measuring range as follows:

Albumin: 0.2- 5.0 g/dL

BUN: 5.5 – 160.1 mg/dL

Calcium: 0.7 – 20.1 mg/dL

Carbon Dioxide: 5- 49 mmol/L

Creatinine: 0.3 – 20.7 g/dL

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The tests are traceable through the appropriate recommended calibrator (Polymedco calibration serum previously cleared under k955489 and CO₂ Standard Verichem previously cleared under k975285) to the Reference material/methods listed in the table below:

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|  Reagent | Reference Material/Method  |
| --- | --- |
|  Albumin | DA470  |
|  BUN | NIST909b  |
|  Calcium | NIST 909b,SRM956b, Atomic absorption  |
|  Carbon Dioxide | Sodium Carbonate Alkametric Standard  |
|  Creatinine | NIST 909b/SRM 967  |

# d. Detection limit:

A limit of detection study was performed according to the CLSI EP17-A guideline. LoB was conducted using a blank sample measured 60 times. LoD and LoQ were conducted using five serum samples containing very low concentrations of the analyte to be tested in replicates of three over four days. LoQ is defined as the concentration at which inter-assay precision is  $\leq 10\%$  CV. LoB, LoD and LoQ are summarized in the table below.

|  Analyte | LoB | LoD | LoQ | Measuring Range  |
| --- | --- | --- | --- | --- |
|  Albumin | 0.0076 g/dL | 0.015g/dL | 0.18g/dL | 0.2 – 5.0 g/dL  |
|  BUN | 0.431 mg/dL | 1.27 mg/dL | 5.5 mg/dL | 5.5 – 160.1 mg/dL  |
|  Calcium | 0.123 mg/dL | 0.246 mg/dL | 0.7 mg/dL | 0.7 – 20.1 mg/dL  |
|  Carbon Dioxide | 0.000 mmol/L | 0.78mmol/L | 5 mmol/L | 5.0 – 49.0 mmol/L  |
|  Creatinine | 0.000 mg/dL | 0.039 mg/dL | 0.29 mg/dL | 0.3 – 20.7 mg/dL  |

# d. Analytical specificity:

An endogenous interfering substances study was performed according to the CLSI EP7-A guideline. Serum samples containing the analyte at three levels of the test were spiked with the potentially interfering substance—hemoglobin, bilirubin and triglyceride—to several concentrations. Samples were then run in triplicate using the Poly-Chem 90 test. The recovery of the test at each concentration of interferents was calculated by comparing the mean result of testing with no interferents to the mean result at each level tested. The sponsor defines non-significant interference as bias  $< 10\%$  between the spiked and unspiked samples. The highest level tested with no significant interference is listed in the table below.

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|  Analyte | Highest level tested with no interference  |   |   |
| --- | --- | --- | --- |
|   |  Hemoglobin | Bilirubin | Triglyceride  |
|  Albumin | 200 mg/dL | 70.7 mg/dL | 612 mg/dL  |
|  BUN | 600 mg/dL | 25 mg/dL | 694 mg/dL  |
|  Calcium | 500 mg/dL | 25 mg/dL | 554 mg/dL  |
|  Carbon Dioxide | 300 mg/dL | 25 mg/dL | 839 mg/dL  |
|  Creatinine | 100 mg/dL | 25 mg/dL | 740 mg/dL  |

The sponsor has the following limitation in their labeling on all the 5 assays based on the hemoglobin study above:

"Do not use hemolyzed samples. Hemolyzed samples will cause erroneous results."

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Patient serum samples with values across the range of the assays were analyzed on the Poly-Chem 180 instrument (predicate device) vs. the Poly-Chem 90 instrument. Samples were run in singlicate for both devices. Samples were as follows: 45 samples (1 spiked, 7 diluted) for Albumin, 50 samples (3 spiked, 1 diluted) for BUN, 50 samples (6 spiked and 4 diluted) for Calcium, 43 samples (5 spiked, 3 diluted) for Carbon Dioxide and 43 samples (2 spiked, 1 diluted) for Creatinine. Results obtained from each instrument were compared using Passing-Bablok analysis. Results are summarized in the table below.

|  Test | n | Range of samples | Slope (95% CI) | Intercept (95% CI) | r  |
| --- | --- | --- | --- | --- | --- |
|  Albumin | 45 | 0.97-4.81 | 0.99 (0.97 - 1.01) | 0.02 (-0.07 - 0.11) | 0.9969  |
|  BUN | 50 | 6.0 – 147.0 | 1.03 (1.01 - 1.04) | -0.20 (-0.69 - 0.43) | 0.9988  |
|  Calcium | 50 | 2.2-18.5 | 1.03 (1.00 - 1.07) | -0.18 (-0.53 - 0.10) | 0.9948  |
|  Carbon Dioxide | 43 | 7 – 49 | 1.00 (1.00 - 1.04) | 1.00 (-0.08 - 1.00) | 0.9966  |
|  Creatinine | 43 | 0.30 – 19.00 | 1.03 (1.02 - 1.06) | -0.13 (-0.20 - 0.07) | 0.9995  |

{12}

b. Matrix comparison:

Serum is the only sample type indicated.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

The expected values are stated within the labeling for each analyte based on the literature. The manufacturer recommends, within the labeling, each laboratory establish its own reference range or reflect the age, sex, diet and geographical location of the population.

Albumin¹: Adult Serum 3.8-5.0 g/dl

BUN²: Serum 5-23 mg/dl

Calcium³: Serum 8.10 – 10.4 mg/dl

CO₂⁴: Serum 20 – 29 mmol/l

Creatinine⁵: Serum Men 0.6 – 1.1 mg/dl

Serum Women 0.5 – 0.9 mg/dl

¹Doumas, B.T., Watson, W.A., Biggs, H.G. Clin. Chem. Acta. 1971;31:87.

²Kerscher, L; Tieqenhorn, J; “Methods of enzymatic Analysis”, H.U. Bergmeyer Ed., VCH Verlagsgesellschaft, Weinham, 1985 3rd Ed; Vd VII

{13}

14

3Barnett, R.N., et al. (1973) Amer. J. Clin. Path. 59:836

4Tietz, NW (Ed.) Fundamentals of clinical chemistry, W.B. Saunders, Co., Toronto, 636-638, 937 (1970)

5Schirmeister, J., H. Willman, and H. Kiefer. (1964). Dtsch. Med. Wschr. 89:1018.

## N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

## O. Conclusion:

The submitted information 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/CIX/K110818](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K110818)

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