POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS

K110818 · Polymedco, Inc. · CIX · Sep 8, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110818
• Device Name: POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
• Applicant: Polymedco, Inc.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Sep 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for quantitative measurement of albumin, BUN, calcium, carbon dioxide, and creatinine in human serum to aid in diagnosis/treatment of liver, kidney, metabolic, parathyroid, and acid-base disorders. For prescription use only.

Regulatory Classification

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The image is in black and white and appears to be a scan or photocopy.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Polymedco Inc. c/o Helen Landicho 510 Furnace Dock Rd. Cortlandt Manor, New York 10567

erp - 8 2011

Re: k110818

> Trade Name: Poly-Chem 90 Albumin. BUN, Calcium, Carbon Dioxide, Creatinine tests Regulation Number: 21 CFR \$862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Codes: CIX, CDQ, CIC, KHS, CGX Dated: August 18, 2011 Received: 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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If you desire specific advice for your device on our labeling regulation (21 CFR Parl 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please poace 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 the reporting 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] br ( 101) 776-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesSorrow/ndustry/default.html

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

Enclosure

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## Indications for Use

510(k) Number (if known): K110818

Device Name: Poly-Chem 90 Albumin, BUN, Calcium, Carbon Dioxide, and Creatinine, tests

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.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Ruto Chesler

Division Sianoff Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 110818

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