AUDIT MICROCV RF/CRP LINEARITY SET

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with a triangular shape at the top, filled with a pattern of small crosses or dots, giving it a textured appearance. Below the triangle, there is text that reads "Aalto Scientific, Ltd." The text is in a simple, sans-serif font and is positioned directly under the triangular symbol. ### 510(k) Summary # KID1226 ## A. Submitter AUG 3 1 2010 Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824 ## B. Contact Person Dessi Lyakov Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com ## C. Date of Summary Preparation April 30, 2010 ## D. Device Identification Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code: Audit™ MicroCV™ RF/CRP Linearity Set Calibration Verification Multi analyte controls (Assayed and Unassayed) Class I 21 CFR 862.1660 75 JJY ## E. Device to Which Substantial Equivalence is claimed Product Trade Name: LiniCAL Calibration Verifier RF/CRP CLINIQA, Fallbrook, CA 92028 K023661 Liquichek Lipids Control Bio-Rad Laboratories, Irvine, California K012513 Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318 نو {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape composed of many small circles or dots, arranged to form a pyramid-like structure. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a stylized font. ## F. Description of the Device The Audit™ MicroCV™ RF/CRP Linearity Set is a 5 level quality control solution set containing C-reactive protein and Rheumatoid Factor as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of RF and CRP. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E. ## G. Statement of Intended Use The Audit™ MicroCV™ RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on manual, automatic, and semi-automatic analyzers. The Audit™ MicroCV™ RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only". ## I. Summary of Performance Data Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ RF/CRP Linearity Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows: Open Vial Stability: Once a vial has been reconstituted, all analytes will be stable for 5 days when stored tightly capped at 2-8 C. Shelf Life: 19 months at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangle made up of many small circles or dots. Below the triangle, the text "Aalto Scientific, Ltd." is written in a stylized font. # H. Technical Characteristics Compared to Predicate Device | Characteristics | AuditTM<br>MicroCVTMRF/CRP<br>Linearity Set (K101226) | Bio-Rad Liquichek<br>Lipids Control<br>(K012513) | AuditTM MicroCVTM<br>General Chemistry<br>Linearity Set (K042318) | LiniCAL<br>Calibration Verifier<br>RF/CRP (K023661) | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The AuditTM<br>MicroCVTM RF/CRP<br>Linearity Set is an<br>assayed quality control<br>material consisting of<br>five levels human based<br>serum. Each level<br>contains Rheumatoid<br>Factor (RF) and C-<br>Reactive Protein (CRP)<br>analytes. The five levels<br>demonstrate a linear<br>relationship to each<br>other for Rheumatoid<br>Factor (RF) and C-<br>Reactive Protein (CRP)<br>analytes. This product<br>may also be used as<br>unassayed quality<br>control material for<br>Rheumatoid Factor<br>(RF) and C-Reactive<br>Protein (CRP) analytes.<br>When used for quality<br>control purposes, it is<br>recommended that each<br>laboratory establish its<br>own means and<br>acceptable ranges and<br>use the values provided<br>only as guides. The<br>product is intended for<br>use with quantitative<br>assays on manual,<br>automatic, and semi-<br>automatic analyzers.<br>The AuditTM<br>MicroCVTM RF/CRP<br>Linearity Set is "For In<br>Vitro Diagnostic Use<br>Only". | Liquichek Lipids<br>Control is intended<br>for use as an<br>assayed quality<br>control serum to<br>monitor the<br>precision of<br>laboratory testing<br>procedures for the<br>listed analytes. | Audit® MicroCVTM General<br>Chemistry Linearity Set<br>consists of five levels of<br>human based serum. Each<br>level contains the following<br>analytes: Albumin, Alkaline<br>Phosphatase, ALT,<br>Amylase, AST, Bilirubin<br>(Total and Direct), BUN,<br>Calcium, Chloride,<br>Cholesterol, CO2 Creatine<br>Kinase, Creatinine, Gamma-<br>GT, Glucose, HDL<br>Cholesterol, Iron, Lactate,<br>LDH, LDL Cholesterol,<br>Lipase, Magnesium,<br>Phosphorus, Potassium,<br>Sodium, Total Protein,<br>Triglycerides and Uric Acid.<br>These five levels<br>demonstrate a linear<br>relationship to each other for<br>their respective analytes,<br>reagents and instruments1.<br>This product may also be<br>used as unassayed quality<br>control material for these<br>analytes. When used for<br>quality control purposes, it<br>is recommended that each<br>laboratory establish its own<br>means and acceptable ranges<br>and use the values provided<br>only as guides. In addition,<br>it may be used for<br>proficiency testing in<br>interlaboratory surveys and<br>to perform CLIA directed<br>calibration verification2 for<br>these same analytes in<br>accordance with current<br>CLIA-88 guidelines and<br>regulations3 | LiniCAL<br>Calibration Verifier<br>RF/CRP is intended<br>for use in the<br>clinical laboratory<br>to objectively verify<br>calibration and<br>assess linearity<br>regarding RF and<br>CRP. Five targeted<br>assayed materials<br>are provided to<br>allow monitoring<br>the manufacturer's<br>reportable range. | | | | | | | | Number of<br>Analytes per vial | 2 | 8 | 31 | 2 | | Number of levels<br>per set | 5 | 2 | 5 | 5 | | Contents | 5 x 1 mL | 2 x 3mL | 5 x 1mL | 5 x 1mL | | Matrix | Human Serum | Human Serum | Human Serum | Human Serum | | Type of Analytes | C-Reactive Protein<br>Rheumatoid Factor | C-Reactive Protein<br>Apolipoprotein A-1<br>Apolipoprotein B<br>Cholesterol<br>HDL Cholesterol<br>LDL Cholesterol<br>Lipoprotein (a)<br>Triglycerides | Albumin, Alkaline<br>Phosphatase, ALT,<br>Amylase, AST, Bilirubin<br>(Total and Direct), BUN,<br>Calcium, Chloride,<br>Cholesterol, CO₂<br>Creatine Kinase.<br>Creatinine, Gamma-GT.<br>Glucose, HDL<br>Cholesterol, Iron.<br>Lactate, LDH, LDL<br>Cholesterol, Lipase.<br>Magnesium, Phosphorus,<br>Potassium, Sodium,<br>Total Protein,<br>Triglycerides and Uric<br>Acid. | Rheumatoid Factor (RF)<br>C-Reactive Protein (CRP) | | Form | Liquid | Liquid | Lyophilized | Liquid | | Storage | 2 to 8° C for 19 months | -20°C to -70°C for 36<br>months | 2 to 8° C for 48 months | 2 to 8° C for 48 months | | Open Bottle<br>Stability | 5 days at 2 to 8° C | 14 days at 2 to 8°C | 7 days at 2 to 8° C | 14 days at 2 to 8°C | : : · {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangle shape made up of many small dots. Below the triangle, the text "Aalto Scientific, Ltd" is written in a simple font. The logo appears to be a simple design. ### J. SIMILARITIES AND DIFFERENCES between the Audit™ MicroCVTMRF/CRP Linearity Set (K101226) and the Predicate Devices Similarities between the Audit™ MicroCV™RF/CRP Linearity Set (K101226) and all Predicate Devices: - . All products are human serum based quality control materials intended to monitor the precision of laboratory testing procedures for the listed analytes. - All products were made using the same method of spiking various constituents to . human based matrix. - All products content multiple levels. 트 - Audit™ MicroCV™RF/CRP Linearity Set (K101226) and LiniCAL Calibration 트 Verifier RF/CRP (K023661) have the same analytes. Diferences between the Audit™ MicroCV™RF/CRP Linearity Set (K101226) and all Predicate Devices: - Audit™ MicroCV™RF/CRP Linearity Set (K101226), Bio-Rad Liquichek . Lipids Control (K012513), and LiniCAL Calibration Verifier RF/CRP (K023661) are liquid products Audit™ MicroCV™ General Chemistry Linearity Set (K042318) is lyophilized product. - Audit™ MicroCVTMRF/CRP Linearity Set (K101226), Bio-Rad Liquichek . Lipids Control (K012513), and LiniCAL Calibration Verifier RF/CRP (K023661) have different analytes. {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Public Health Service Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993 AUG 3 1 2010 Aalto Scientific, Ltd. c/o Ms. Dessi Lyakov Manager, Regulatory Affairs 1959 Kellogg Ave. Carlsbad, CA 92008 Re: k101226 Trade/Device Name: Audit™ MicroCV™ RF/CRP Linearity Set Regulation Number: 21 CFR§862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I (Reserved) Product Code: JJY Dated: August 18, 2010 Received: August 18, 2010 Dear Ms. Lyakov: 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 class II (Special Controls), 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 {5}------------------------------------------------ #### Page 2 - Ms. Dessi Lyakov CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. > Sincerely vours. marrow in chan Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features the company name in a simple, sans-serif font, with the word "Aalto" slightly larger than "Scientific, Ltd." Above the text is a triangular shape composed of many small dots, creating a textured, geometric design. The overall impression is clean and professional. ## Indications for Use 510(k) Number: K101226 Device Name: Audit™ MicroCV™ RF/CRP Linearity Set Indications For Use: The Audit™ MicroCV™ RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on manual, automatic, and semi-automatic analyzers. The Audit™ MicroCVTM RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only". Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) AUG 3 1 2010 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Reena Philip Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510K k10/226