MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H

{0}------------------------------------------------ APR 2 1. 2005 K050576 # 510(k) Summary # Safety and Effectiveness "This summary of 510(k) safety and effectiveness information is being submitted in summary of be of to(s) == accordance with the requirements of SMDA 1990 and 21 CFR 807.92." ## Microalbumin TIA/ mAlb Calibrator Set 200/ mAlb Control-L, Control-H #### Submitter Good Biotech Corp. Name, 38 34th Rd. Taichung Industrial Park Taichung City 407 Taiwan Address, +886-4-23596873 Telephone number, Victor Chiou Contact person, February 18, 2005 Preparation date #### Device | Trade name, | Microalbumin TIA Reagent | |---------------------|----------------------------------------------------------------------| | | mAlb Calibrator Set 200 | | | mAlb Control-L, Control-H | | Common name, | Urinary albumin immunological diagnostic assay | | | Albumin calibrator | | | Albumin control | | Classification name | Albumin immunological test system (21 CFR § 866.5040) | | | Calibrator (21 CFR § 862.1150) | | | Quality control material (assayed and unassayed) (21 CFR § 862.1660) | | Predicate Device | | | Trade name, | Randox Microalbumin Test kit | | | Wako Micro-Albumin B/ Wako Micro Albumin Calibrator | | 510(k) number | K002674 | | | K944664 | {1}------------------------------------------------ #### Description Good Biotech Corp. Microalbumin TIA is a ready to use reagent for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). When microalbumin of the urine sample encounters with duck anti-albumin antibody, the agglutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 340 nm is proportional to the albumin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual microalbumin concentration of the urine sample is determined by interpolation of the calibration curve obtained by standard samples with known albumin concentrations. #### Intended Use #### Reagent: Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease. #### Calibrator: GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples. #### Control: GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis. For In Vitro Diagnostic Use. #### Substantial Equivalence Comparative performance studies conducted on 50 urine samples yielded high correlation coefficients upon comparison of the GBC Microalbumin TIA system and the predicate devices, Randox Microalbumin Test kit and Wako Micro-Albumin B. The results are summarized below: {2}------------------------------------------------ | Comparative Method | Slope | Intercept<br>(mg/L) | Correlation<br>Coefficient | n | |----------------------|-------|---------------------|----------------------------|----| | Randox | 1.20 | -0.56 | 0.997 | 50 | | Wako Micro-Albumin B | 1.20 | -2.17 | 0.998 | 50 | #### Conclusion Good Biotech Corp. Microalbumin TIA system, calibrator set and controls are substantially equivalent to the predicate devices based on their intended purposes, design and the comparison performance results. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. APR 2 1 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Victor Chiou President Good Biotech Corp. 38, 34th Road Taichung Industrial Park Taichung City Taiwan 407 k050576 Re: K050570 Trade/Device Name: Microalbumin TIA Reagent; mA1b Calibrator Set 200; mA1b Control- L, Control- H Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DDZ, JIT, JJX Dated: March 3, 2005 Received: March 7, 2005 Dear Mr.Chiou: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) free is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally at the Medical Device Amendments, or to commerce provision to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require to the general controls provisions of the Act. The 1 ou may, mercione, market the act include requirements for annual registration, listing of general controls provisions of the rice, 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 in the lice it may be subject to such additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 Can be found in Thee 21, Courtents concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a studenice complies with other requirements of the Act that I DA has made a decommandia an administered by other Federal agencies. You must of ally reactal statutes and regulations and limited to: registration and listing (21 {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely yours, Jean M. Cooper MS, DUM Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use ### 510(k) Number (if known): K050576 ### Device Name: Microalbumin TIA Reagent ; mAlb Calibrator Set 200 ; mAlb Control-L, Control-H #### Indications For Use: Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative Oood Blotton of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease. GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples. GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis. For In Vitro Diagnostic Use. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Carol C Benson Divison Mgr-Off Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of __ 1 __ K050576 D-1