EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

K101089 · Medica Corp. · DCF · Jul 13, 2011 · Immunology

Device Facts

• Record ID: K101089
• Device Name: EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
• Applicant: Medica Corp.
• Product Code: DCF · Immunology
• Decision Date: Jul 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

The EasyRA µALB reagent is intended for the quantitative determination of micro-albumin in human urine, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Micro-albumin measurements using immunological tests aid in the diagnosis of kidney diseases. The EasyRA micro-albumin (µALB) calibrator facilitates measurements of µALB on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's µALB reagent. The µALB calibrator is used to establish points of reference that are used in the determination of values in the measurement of µALB in human urine.

Device Story

EasyRA micro-albumin (µALB) Reagent and Calibrator are in vitro diagnostic components for use on the Medica EasyRA Chemistry Analyzer. The reagent utilizes an immunological test method to quantify micro-albumin in human urine samples. The calibrator establishes reference points for the analyzer to ensure accurate measurement values. The system is intended for use by trained laboratory personnel in clinical settings. Results assist clinicians in the diagnosis of kidney diseases. The device operates as part of an automated clinical chemistry workflow.

Clinical Evidence

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

Technological Characteristics

Immunoturbidimetric assay. Reagents: R1 (buffer/preservative), R2 (goat anti-human albumin antibody). Calibrators: human albumin in saline (Tris/NaCl). Measurement: 340 nm and 700 nm. Form factor: liquid, ready-to-use. Connectivity: RFID tag on reagent wedge for parameter storage. Sterilization: N/A (in vitro diagnostic reagent).

Indications for Use

Indicated for quantitative determination of microalbumin in human urine to aid in the diagnosis of kidney diseases. For prescription use in clinical laboratories.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

Image /page/0/Picture/4 description: The image shows the date "JUL 13 2011" in bold, black font. The letters and numbers are closely spaced together. The date is likely extracted from a document or photograph.

Medica Corp. c/o Dr. Photios Makris Director of Regulatory Affairs 5 Oak Park Drive Bedford, MA 01730

> Re: k101089 Trade Name: EasyRA micro-albumin (uALB) Reagent and EasyRA microalbumin (uALB) Calibrator Regulation Number: 21 CFR 862.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Codes: DCF, JIT Dated: June 30, 2011 Received: July 01, 2011

## Dear Dr. Makris:

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 Parts 801 and 809), please contact the Office of In Vitro 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 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] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

G.C.

Courtney Harper, 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):

| Device Name: | EasyRA micro-albumin (µALB) Reagent |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The EasyRA µALB reagent is intended for the quantitative determination of micro-albumin in human urine, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Micro-albumin measurements using immunological tests aid in the diagnosis of kidney diseases. |
| Device Name: | EasyRA micro-albumin (µALB) Calibrator |
| Indications For Use: | The EasyRA micro-albumin (µALB) calibrator facilitates measurements of µALB on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's µALB reagent. The µALB calibrator is used to establish points of reference that are used in the determination of values in the measurement of µALB in human urine. |

Prescription Use X (Part 21 CFR 801 Subpart D)

. 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)

enson Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Page 1 of