POLY-CHEM 90 TOTAL BILIRUBIN

K111143 · Polymedco, Inc. · CIG · Sep 1, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111143
• Device Name: POLY-CHEM 90 TOTAL BILIRUBIN
• Applicant: Polymedco, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Sep 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Device Story

Poly-Chem 90 Total Bilirubin is an in vitro diagnostic reagent system used on the Poly-Chem 90 clinical chemistry analyzer. The device measures total bilirubin levels in human serum samples. Operation utilizes a colorimetric method based on the Jendrassik and Grof (1938) principle; bilirubin reacts with diazotized sulphanilic acid in the presence of caffeine, which releases albumin-bound bilirubin. The analyzer performs the measurement and provides quantitative output. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing and monitoring liver, hemolytic, and metabolic disorders. The device provides a diagnostic tool for assessing bilirubin levels associated with red blood cell destruction.

Clinical Evidence

No clinical data. Performance established via bench testing: precision (intra-assay %CV 0.2-1.6%, inter-assay %CV 4.3-5.4%), linearity (0.1-27.5 mg/dL), and analytical specificity (no interference up to 600 mg/dL hemoglobin and 554 mg/dL triglyceride). Method comparison against predicate (n=82) showed high correlation (r=0.9998, slope 0.98).

Technological Characteristics

Colorimetric reagent system for total bilirubin measurement. Sensing principle: chemical reaction with diazotized sulphanilic acid in the presence of caffeine. Form factor: reagent kit for use on the Poly-Chem 90 clinical chemistry analyzer. Measuring range: 0.1–27.5 mg/dL. Storage: 15–25°C.

Indications for Use

Indicated for quantitative in vitro measurement of total bilirubin in human serum to aid in diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders (e.g., hepatitis, gall bladder block).

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

• Poly-Chem® Total Bilirubin (K973995)

Submission Summary (Full Text)

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YMEDCO inc. Corporate Office

K11143 510 Furnace Dock Road, Cortlandt Manor, NY 10567

Tel: [phone] FAX [phone] Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone]

FAX: [phone]

#### 510(k) Summary

SEP - 1 2011

Address: Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567

Helen Landicho

Phone: [phone] [phone] (fax)

Summary prepared July 14, 2011

Contact Person:

| 510(k) number: | K111143 |
|---------------------|--------------------------------------------------------------------------------------|
| Name of the device: | Poly-Chem® 90 Total Bilirubin |
| Device common name: | Total Bilirubin reagent/test system |
| Product code: | CIG |
| Regulation number: | 862.1110 |
| Classification: | Class II |
| Predicate Device: | Poly-Chem® Total Bilirubin |
| Device common name: | Total Bilirubin reagent/test system |
| 510(k) number: | K973995 |
| Manufacturer: | Randox Laboratories Ltd.,<br>55 Diamond Road, Crumlin,<br>Co. Antrim, United Kingdom |

BT29 4QY

862.1110

Class II

CIG

Product code: Regulation number: Classification:

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro Device Description: measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. The test methodology is a colorimetric method based on that described by Jendrassik and Grof (1938). Total bilirubin is determined in the presence of caffeine, which releases albumin bound bilirubin, by the reaction with diazotized sulphanilic acid.

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro Intended use: measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level

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POLYMEDCO inc. Corporate Office

510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: [phone] FAX [phone]

| Seattle Office | 9750 Third Ave NE Ste. 100, Seattle, WA 98115 |
|----------------|-----------------------------------------------|
| | Tel: [phone]<br>FAX: [phone] |

of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders. including hepatitis and gall bladder block.

# Similarities and Differences with Predicate Device

| Similarities and Differences Total Bilirubin | | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Poly-Chem 90 Total Bilirubin | Poly-Chem Total Bilirubin |
| Intended Use | For the quantitative in vitro<br>measurement of the level of total<br>bilirubin in human serum on the<br>Poly-Chem 90 analyzer. | For the quantitative in vitro<br>measurement of the level of total<br>bilirubin in human serum and<br>plasma on the Poly-Chem<br>analyzer. |
| Indications for Use | Measurements of the level of<br>bilirubin, an organic compound<br>formed during the normal and<br>abnormal destruction of red blood<br>cells, are used in the diagnosis<br>and treatment of liver, hemolytic<br>hematological, and metabolic<br>disorders, including hepatitis and<br>gall bladder block. | Same |
| Sample type | Serum | Serum and plasma |
| Test methodology | Colorimetric | Same |
| Precision | Intraassay: %CV from 0.4% to 1.7%<br>Interassay: %CV from 4.3% to 5.4%<br>Samples from 0.50 to 25.71 g/dL | Intraassay: %CV from 2.1% to 2.3%<br>Interassay: %CV from 1.4% to 1.9%<br>Samples from 0.92 to 5.29 mg/dL |
| Measuring range | 0.1-27.5 mg/dL | 0.09 - 25 mg/dL |
| Comparison with<br>Predicate | $y = 0.98x - 0.03, r = 0.9998$ ; 82<br>samples from 0.10 - 24.10 mg/dL | $y = 0.93x + 0.02, r = 0.98$ ; 33<br>samples from 0.09 – 4.86 mg/dL |
| Storage | 15 - 25°C | Same |
| Stability | Same | Same |
| Expected values | Adults: up to 1 mg/dl (17 µmol/l) | Same |
| Reagent Kit | Same | Same |
| Analyzer | Poly-Chem 90 | Poly-Chem 180 |

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OLYMEDCO inc. Corporate Office

510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: [phone] FAX [phone]

Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone] FAX: [phone]

## Summary of performance testing

To demonstrate substantial equivalence, performance characteristics that were tested included precision, linearity, sensitivity, interferences, and method comparison. Results of this testing are summarized below. The results indicate that Poly-Chem 90 Total Bilirubin is substantially equivalent to currently marketed Total Bilirubin reagent test systems.

#### Precision

| | | | Within run | | Between run | |
|--------|------------|-------|------------|------|-------------|------|
| Sample | Instrument | Mean | SD | CV | SD | CV |
| 1 | 1 | 0.50 | 0.008 | 1.65 | 0.027 | 5.40 |
| 1 | 2 | 0.50 | 0.006 | 1.19 | 0.025 | 5.10 |
| 2 | 1 | 5.02 | 0.021 | 0.42 | 0.215 | 4.29 |
| 2 | 2 | 4.98 | 0.032 | 0.65 | 0.225 | 4.51 |
| 3 | 1 | 25.71 | 0.059 | 0.23 | 1.270 | 4.94 |
| 3 | 2 | 25.42 | 0.249 | 0.98 | 1.336 | 5.26 |

Linearity of the test 0:07 – 27.5 mg/dL

#### Sensitivity

| Limit of Blank | Limit of Detection | Limit of Quantitation<br>(10% CV) |
|----------------|--------------------|-----------------------------------|
| 0.0043 mg/dL | 0.0184 mg/dL | 0.08 mg/dL |

#### Interference

Highest level tested with no interference: Hemoglobin 600 mg/dL Triglyceride 554 mg/dL

#### Comparison with predicate device

| n | Range of samples | Slope<br>(95% CI) | Intercept<br>(95% CI) | r |
|----|------------------|------------------------|---------------------------|--------|
| 82 | 0.10 - 24.10 | 0.98<br>(0.98 to 0.99) | -0.03<br>(-0.04 to -0.01) | 0.9998 |

### Conclusions

Poly-Chem 90 Total Bilirubin is substantially equivalent to currently marketed Total Bilirubin reagent test systems.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Polymedco. Inc c/o Helen Landicho, RAC Vice President, Regulatory Affairs 510 Furnace Dock Rd Cortlandt Manor . New York. 10567 Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

SEP 0 1 2011

Re: K11143 Trade name: Regulation Number: Regulation Name: Regulatory Class: Product Codes: Dated: Received:

Poly-Chem ® 90 Total Bilirubin 21CFR \$862.1110 Total Bilirubin test system Class II CIG August 18, 2011 August 22, 2011

Dear Ms. Landicho.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, 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 can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: Poly-Chem 90 Total Bilirubin test

Indications For Use:

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

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

Signature

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 111143