← Product Code [CFR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFR) · K090703

# POLY-CHEM 90 GLUCOSE (K090703)

_Polymedco, Inc. · CFR · Oct 20, 2009 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFR/K090703

## Device Facts

- **Applicant:** Polymedco, Inc.
- **Product Code:** [CFR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFR.md)
- **Decision Date:** Oct 20, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Pediatric

## Indications for Use

The Poly-Chem 90 glucose test system is an in vitro diagnostic procedure intended to measure qlucose quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypodycemia. and idiopathic glycemia, and of the pancreatic isle cell carcinoma. The Poly-Chem 90 ALP test system is an in vitro diagnostic procedure intended to measure alkaline phosphatase quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Measurements of alkaline phosphatase are of use in the diagnosis, treatment, and investigation of hepatobiliary disease and in bone disease associated with increased osteoblastic activity. Alkaline phosphatase is also used in the diagnosis of parathyroid and intestinal disease. The Poly-Chem 90 AST test system is an in vitro diagnostic procedure intended to measure aspartate aminotransferase (AST) quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. AST measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

## Device Story

Poly-Chem 90 system performs quantitative in vitro diagnostic analysis of glucose, ALP, and AST in human serum and plasma; utilizes Poly-Chem 90 analyzer; intended for clinical laboratory use; provides quantitative concentration values to healthcare providers; aids in diagnosis and management of metabolic, hepatic, bone, and cardiac conditions.

## Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the assay system.

## Technological Characteristics

In vitro diagnostic test system for use on the Poly-Chem 90 analyzer; quantitative photometric measurement principle; utilizes chemical reagents for glucose, ALP, and AST detection in serum and plasma samples.

## Regulatory Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

## Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k090703

B. Purpose for Submission:
Introduction of new analyzer to measure glucose, alkaline phosphatase (ALP) and aspartate amino transferase (AST)

C. Measurand:
Glucose, ALP, AST

D. Type of Test:
Quantitative, Photometry

E. Applicant:
Polymedco, Inc.

F. Proprietary and Established Names:
Poly-Chem 90 Glucose, ALP, and AST

G. Regulatory Information:

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  CFR – Hexokinase, Glucose | Class II | 21 CFR 862.1345 – Glucose Test System. | 75 Clinical Chemistry(CH)  |
|  Product Code | Classification | Regulation Section | Panel  |
|  CJE - Alkaline Phosphatase | Class II | 21 CFR 862.1050 Alkaline phosphatase Test System | 75 Clinical Chemistry(CH)  |
|  Product Code | Classification | Regulation Section | Panel  |
|  CIT- NADH oxidation/NAD reduction, AST/SGOT | Class II | 21 CFR 862.1100 Aspartate amino transferase (AST/SGOT) test system | 75 Clinical Chemistry(CH)  |

H. Intended Use:

1. Intended use(s):
See Indications for use below.

2. Indication(s) for use:

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The Poly-Chem 90 glucose test system is an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic isle cell carcinoma.

The Poly-Chem 90 ALP test system is an in vitro diagnostic procedure intended to measure alkaline phosphatase quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Measurements of alkaline phosphatase are of use in the diagnosis, treatment, and investigation of hepatobiliary disease and in bone disease associated with increased osteoblastic activity. Alkaline phosphatase is also used in the diagnosis of parathyroid and intestinal disease.

The Poly-Chem 90 AST test system is an in vitro diagnostic procedure intended to measure aspartate aminotransferase (AST) quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. AST measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

3. Special conditions for use statement(s):

For in vitro diagnostic use only.

4. Special instrument requirements:

Poly-Chem 90 Analyzer

I. Device Description:

The Poly-Chem 90 is a bench-top fully automated random access clinical analyzer. It has the capacity to perform up to 90 tests per hour plus ISEs, and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment. Principles of measurement include two end-point methods, a single and double measurements and a rate-method.

Glucose kit contains two reagents: buffer/coenzyme and diluent, and enzyme reagent. ALP kit contains buffer and substrate. AST kit contains enzyme and oxaloglutarate and coenzyme.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Poly-chem glucose

2. Predicate 510(k) number(s):

k020852, k923507, k923505

3. Comparison with predicate:

The assays are similar in design and intended use. Similarities and differences of the instruments are outlined below.

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|   |   | Predicate (k020852) Poly-Chem 180 | New Device (k090703) Poly-Chem 90  |
| --- | --- | --- | --- |
|  Type |   | Desktop fully automated random access analyzer | Same  |
|  Through put |   | 180 tests per hour (Up to 450 tests per hour with ISE) | 90 tests per hour (Up to 156 tests per hour with ISE)  |
|  Incubation time | 5 minutes after applying sample for one reagent assay | Same  |   |
|   |   |  5 minutes after applying second reagent for 2 reagents assay | Same  |
|  Sample type |   | Serum, Plasma | Same  |
|  Sample input system | Type | Removable tray with sample tube holder on a turntable | Same  |
|   |   |  Barcode sample ID detection with optional barcode reader | Same  |
|   |  Capacity | Up to 40 samples | Up to 20 samples  |
|  Sampling pipette | Type | Micro-pipette with liquid level detector | Same  |
|   |  Rinsing | Inside and outside with purified water | Same  |
|  Sampling pump | Type | Micro syringe | Same  |
|   |  Volume | 2 to 35 μl | Same  |
|  Reagent system | Type | Removable tray with reagent bottle holder on a turntable | Same  |
|   |   |  Barcode reagent ID detection with barcode reader | Same  |
|   |  Capacity | 40 reagent positions on a tray | 20 reagent positions on a tray  |
|   |  Inventory | Calculation of remaining reagent volume available | Same  |
|   |  Cooling | Cooling with Peltier element | Same  |
|  Reagent pipette | Numbers of pipettors | 1 | Same  |
|   |  Type | Micro-pipette with liquid level detector | Same  |

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|   |   | Predicate (k020852) Poly-Chem 180 | New Device (k090703) Poly-Chem 90  |
| --- | --- | --- | --- |
|   | Rinsing | Inside and outside with purified water | Same  |
|   |  Number of reagents | Up to 2 reagents | Same  |
|   |  Inventory | Calculation of remaining reagent volume available | Same  |
|  Reagent pump | Type | Micro syringe | Same  |
|   |  Volume | 20 to 400 μl | Same  |
|  Cuvette system | Number of cuvettes | 45 cuvettes on reaction line | Load on as needed  |
|   |  Type | Reusable with onboard washing system | Disposable  |
|   |  Volume for measurement | Minimum 180 μl | Same  |
|   |  Maximum volume | 500 μl in total | Same  |
|  Reaction system | Type | Direct heating system | Same  |
|   |  Temperature | 37 degree Celsius ± 0.3 | Same  |
|  Detector | Method | Direct measurement of absorbance in cuvette | Same  |
|   |   |  Bi-chromatic or Mono-chromatic | Same  |
|   |  Wavelength | 8 selectable from 340 nm to 900 nm | 8 selectable from 340 to 800 nm  |
|   |  Light source | Halogen tungsten lamp | Same  |
|  Stirring system | Type | Stick type rotating stirrer | Same  |
|  Dimensions |   | 770 mm (W) x 620 mm (D) x 505 mm (H) | 620mm (W) × 555 mm (D) × 570mm (H)  |
|  Mass |   | 135 kg | 65 kg  |

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K. Standard/Guidance Document Referenced (if applicable):
- CLSI EP-5A2: Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline
- CLSI EP-6A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
- CLSI EP-17-A: Protocols for Determination of Limit of Detection and limit of Quantitation, Approved Guideline
- ISO 14971: Medical devices – Application of risk management to medical devices.
- IEC 61010-1 2001 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General
- IEC 61010-2-101: 2002 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Particular requirements for In Vitro Diagnostic (IVD) Medical Equipment
- EN 61326:1997: Measurement, Control and test device – EMC requirement

L. Test Principle:

Glucose:

Glucose measurements are obtained by enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase. Glucose is phosphorylated with adenosine triphosphate (ATP) in the reaction catalyzed by hexokinase (HK). The product, glucose-6-phosphate (G6P) is then oxidized with the concomitant reduction of nicotinamide adenine dinucleotide (NAD) to NADH in the reaction catalyzed by glucose-6-phosphate-dehydrogenase (G6PDH). The formation of NADH causes increases in absorbance, which is directly proportional to the amount of glucose in the sample.

AST:

Aspartate aminotransferase (AST) catalyzes the transfer of the amino group from Laspartate to 2-oxoglutarate to yield oxalacetate and L-glutamate. The oxaloacetate undergoes reduction with simultaneous oxidation of NADH to NAD in the malate dehydrogenase (MDH) catalyzed indicator reaction. The resulting rate of decrease in absorbance is directly proportional to the AST activity.

ALP:

ALP catalyzes the hydrolysis of p-nitrophenylphosphate (p-NPP). The formation of p-nitrophenol in alkaline solution is followed at a wavelength of 405 nm.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision testing for glucose, ALP, and AST were performed on 4 levels of serum samples across the assay measuring range. Within run precision for each level was conducted using 20 replicates in one run of Poly-Chem 90 instrument. Between run precision was tested using 20 replicates in each of 20 instrument runs. Results for each analyte are summarized in the tables below.

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|  Test | Level | Intrassay precision |   |   | Interassay precision  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Mean | SD | %CV | Mean | SD | %CV  |
|  Glucose | Level 1 | 37.7 | 0.59 | 1.6% | 37.2 | 0.81 | 2.2%  |
|   |  Level 2 | 110.0 | 1.72 | 1.6% | 113.4 | 2.01 | 1.8%  |
|   |  Level 3 | 273.4 | 3.12 | 1.1% | 281.7 | 5.04 | 1.8%  |
|   |  Level 4 | 585.4 | 8.75 | 1.5% | 576.6 | 5.27 | 0.9%  |
|  ALP | Level 1 | 25.1 | 0.22 | 0.9% | 23.4 | 0.5 | 2.1%  |
|   |  Level 2 | 107.4 | 0.94 | 0.9% | 100.8 | 3.53 | 3.5%  |
|   |  Level 3 | 360.8 | 3.67 | 1.0% | 355.7 | 9.38 | 2.6%  |
|   |  Level 4 | 809.9 | 9.68 | 1.2% | 802.3 | 9.45 | 1.2%  |
|  AST | Level 1 | 15.9 | 0.85 | 5.4% | 15.9 | 0.99 | 6.2%  |
|   |  Level 2 | 33.0 | 1.34 | 4.1% | 33.2 | 1.20 | 3.6%  |
|   |  Level 3 | 142.0 | 1.45 | 1.0% | 142.2 | 1.06 | 0.7%  |
|   |  Level 4 | 481.4 | 5.45 | 1.1% | 432.8 | 15.78 | 3.6%  |

# b. Linearity/assay reportable range:

The linearity of each analyte on Poly-Chem 90 system was tested using two serum samples (high and low) mixed to obtain the linearity panel with 12 concentration levels for each analyte (Glucose:  $32.7 - 632\mathrm{mg / dL}$ ;  $22.3 - 858.3\mathrm{IU / L}$ ; AST:  $12.7 - 523.3\mathrm{IU / L}$ ). The summary of linear regression analysis of data for 3 analytes is given in the table below.

|  Test | Range | Slope (95% CI) | Intercept (95% CI) | r  |
| --- | --- | --- | --- | --- |
|  Glucose | 32 – 632 mg/dL | 1.01 (0.99 – 1.02) | 2.28 (-3.20 – 7.75) | 0.9998  |
|  ALP | 22 – 858 IU/L | 0.99 (0.97 – 1.01) | 4.46 (-3.90 – 12.81) | 0.9997  |
|  AST | 13 – 523 IU/L | 1.00 (0.99 – 1.02) | -2.95 (-6.36 – 0.46) | 0.9990  |

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability protocols and acceptance criteria were previously reviewed under k020852.

# d. Detection limit:

Following CLSI EP-17-A (Protocols for Determination of Limit of Detection and limit of Quantitation, Approved Guideline), the sponsor conducted studies to determine the limit of detection (LOD) and limit of quantitation (LOQ). The results for 3 analytes are summarized in the table below.

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|  Test | Limit of Detection | Limit of Quantitation (10% CV)  |
| --- | --- | --- |
|  Glucose | 0.48 mg/dL | 3 mg/dL  |
|  ALP | 1.70 IU/L | 5 IU/L  |
|  AST | 3.64 IU/L | 12 IU/L  |

e. Analytical specificity:

The sponsor conducted interference studies to evaluate the interference from bilirubin and triglycerides, and hemolysis for glucose, ALP, and AST. Serum samples containing 3 levels of each analyte (glucose: 45, 102, and 516 mg/dL; ALP: 32, 104, 793 IU/L; AST: 29, 246, 501 IU/L) were used to spike the interfering substances at different concentrations to evaluate the bias in reference to the unspiked samples. Based on the acceptable recovery of analytes between 90-100%, the results summarized in the table below indicate the interference limits. The sponsor recommends that users should not use hemolyzed samples for ALP and AST testing.

|  Test | Highest concentration with no interference  |   |   |
| --- | --- | --- | --- |
|   |  Hemoglobin | Bilirubin | Triglyceride  |
|  Glucose | 800 mg/dL | 67.6 mg/dL | 2321.4 mg/dL  |
|  ALP | 200 mg/dL | 17 mg/dL | 2010 mg/dL  |
|  AST | 200 mg/dL | 25 mg/dL | 534 mg/dL  |

f. Assay cut-off:

Not Applicable.

2. Comparison studies:

a. Method comparison with predicate device:

The sponsor conducted method comparison studies to evaluate the accuracy of glucose, ALP, and AST in comparison to the predicate device. The sponsor used 3 different reagent lots for each of the analyte tested in the method comparison. The number of patient serum samples and the sample range for each analyte, and the results are given in the table below.

|  Test | n | Range of samples | Slope (95% CI) | Intercept (95% CI) | r  |
| --- | --- | --- | --- | --- | --- |
|  Glucose | 63 | 43 – 408 mg/dL | 0.99 (0.97 to 1.00) | -3.11 (-4.00 to -0.70) | 0.9979  |
|  ALP | 47 | 35 – 784 U/L | 0.99 (0.99 to 1.00) | 0.72 (0.00 to 1.54) | 0.9994  |
|  AST | 47 | 10 – 494 U/L | 0.99 (0.97 to 1.00) | -1.74 (-2.00 to 0.00) | 0.9997  |

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b. Matrix comparison: Not applicable

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 sponsor references the following reference ranges:

Expected values for serum and plasma glucose is 70-105 mg/dL
Expected values for serum ALP:

|  Men | 30 - 90 U/L | 30°C  |
| --- | --- | --- |
|  Women up to 40 years | 30- 90 U/L | 30°C  |
|  Women over 40 years | 30-100 U/L | 30°C  |
|  Children 3-15 years | 117-390 U/L | 37°C  |
|  Adults | 39-117 U/l | 37°C  |

Expected values for serum AST:

|   | 25°C | 30°C | 37°C  |
| --- | --- | --- | --- |
|  Men | Up to 18 U/L | Up to 25 U/L | Up to 37 U/L  |
|  Women | Up to 15 U/L | Up to 21 U/L | Up to 31 U/L  |

The sponsor recommends that each laboratory establish its own reference range.

N. Instrument Name:

PolyChem 90

O. System Descriptions:

1. Modes of Operation: Desktop fully automated random access analyzer

2. Software: FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes ☐ or No ☑

3. Specimen Identification: Manual or barcode entry with optional barcode reader

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4. Specimen Sampling and Handling:
Removable tray with sample tube holder on a turntable. On-board sampling dilution capability

5. Calibration:
Calibration uses a factor calculation and a no reagent blank. Each new reagent lot should be checked for proper calibration.

6. Quality Control:
Use of quality control materials are recommended for daily runs.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: Not applicable

Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFR/K090703](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFR/K090703)

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