DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 8, 2014 DIAMOND DIAGNOSTICS, INC KATHY CRUZ QUALITY ASSURANCE MANAGER 333 FISKE ST HOLLISTON MA 01746 Re: K133751 Trade/Device Name: Diamond Diagnostics ISE Serum Standards. Diamond Diagnostics ISE Urine Standards Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: June 23, 2014 Received: June 24, 2014 Dear Ms. Cruz: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Courtney Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k133751 #### Device Name Diamond Diagnostics ISE Serum Standards, Diamond Diagnostics ISE Urine Standards #### Indications for Use (Describe) Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Serum mode. Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Urine mode. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92 | Applicant: | Diamond Diagnostics Inc<br>333 Fiske Street<br>Holliston MA 01746 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Kathy Cruz<br>Quality Assurance Manager<br>Phone: (508) 429-0450 ext. 358<br>Fax: (508) 429-0452<br>www.diamonddiagnostics.com | | Date Prepared: | 08/05/14 | | Classification Name: | Calibrator, secondary | | Trade Name: | Diamond Diagnostics ISE Serum Standards<br>Diamond Diagnostic ISE Urine Standards | | Device Classification: | 21 CFR 862.1150 | | Device Class: | Class II | | Classification Panel: | Clinical Chemistry (75) | | Product Code: | JIT | | Indications for Use: | Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide<br>calibration points for the sodium, potassium and chloride electrodes on ADVIA Chemistry<br>systems in Human Serum mode.<br>Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide<br>calibration points for the sodium, potassium and chloride electrodes on ADVIA Chemistry<br>systems in Human Urine mode. | | Description of Device: | Diamond Diagnostics ISE Serum Standards and ISE Urine Standards are intended to serve<br>as a direct replacement to Siemens (Bayer) Advia ISE Serum Standards and ISE Urine<br>Standards.<br>Diamond Diagnostics ISE Serum Standards consists of an aqueous buffered solution of<br>electrolytes, and preservative in Deionized water. It contains NO human or animal products<br>It is a liquid packaged in a 100mL high density polyethylene (HDPE) dropper bottle. It<br>consists of one Serum Low Standard and one Serum High Standard sold as a set in a box. | {4}------------------------------------------------ The Serum Standards are comprised of the following concentrations of analytes. | | Na+<br>mmol/L | K+<br>mmol/L | Cl-<br>mmol/L | |----------------------------|---------------|--------------|---------------| | ISE Serum<br>Standard Low | 130 ± 2 | 3.5 ± 0.05 | 85 ± 2 | | ISE Serum<br>Standard High | 160 ± 2 | 6.0 ± 0.05 | 120 ± 2 | Diamond ISE Urine Standards consists of an aqueous buffered solution of electrolytes, and preservative in Deionized water. It contains NO human or animal products. It is a liquid packaged in a 100mL HDPE dropper bottle. It consists of one Urine Low Standard and one Urine High Standard sold as a set in a box. The Urine Standards are comprised of the following concentrations of analytes. | | Na+<br>mmol/L | K+<br>mmol/L | Cl-<br>mmol/L | |----------------------------|---------------|--------------|---------------| | ISE Urine<br>Standard Low | $50 \pm 2$ | $10 \pm 0.2$ | $50 \pm 2$ | | ISE Urine<br>Standard High | $200 \pm 3$ | $100 \pm 2$ | $180 \pm 2$ | Predicate Device: Diamond Diagnostics ATAC 8000/Envoy 500 ISE Serum Calibrators Predicate 510(k) number(s): k121027 #### Comparison with predicate: Diamond Diagnostics ISE Serum Standards | Characteristics | Candidate Device<br>Diamond Diagnostics ISE Serum Standards (Low and High) | Predicate Device<br>Diamond Diagnostics ATAC 8000/Envoy 500 ISE Serum Calibrators (k121027) | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Product Type | Calibrator | same | | Intended Use | For in-vitro diagnostics use in the calibration of sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Serum mode. | For in-vitro diagnostics use in the calibration of sodium, potassium, chloride and CO2 electrodes on ATAC 8000/Envoy 500 Chemistry systems. | | Matrix | Aqueous buffered solution of salts & preservatives in Deionized water. Contains NO human or animal materials. | same | | Levels | Low and High | same | | Packaging | 100mL HDPE Dropper Bottle, sold as a set of 1 each High and Low Standard | 2 x 20mL Glass Vial | | Storage | 18-25 °C | same | | Shelf Life | 24 months | same | | Open-Vial Stability | 30 Day | Use immediately after opening | {5}------------------------------------------------ #### Diamond Diagnostics ISE Urine Standards | | Similarities and Differences | | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Candidate Device Diamond Diagnostics ISE<br>Urine Standards (Low and High) | Predicate Device<br>Diamond Diagnostics ATAC<br>8000/Envoy 500 ISE Serum<br>Calibrators (k121027) | | Product Type | Calibrator | same | | Intended Use | For in-vitro diagnostics use in the calibration of<br>sodium, potassium, and chloride electrodes on<br>ADVIA Chemistry systems in Urine mode. | For in-vitro diagnostics use in<br>the calibration of sodium,<br>potassium, chloride and CO2<br>electrodes on ATAC 8000/<br>Envoy 500 Chemistry systems. | | Matrix | Aqueous buffered solution of salts & preservatives<br>in Deionized water. Contains NO human or animal<br>materials. | same | | Levels | Low and High | same | | Packaging | 100mL HDPE Dropper Bottle, sold as a set of 1<br>each High and Low Standard | 2 x 20mL Glass Vial | | Storage | 18-25℃ | same | | Shelf Life | 24 months | same | | Open-Vial Stability | 30 Day | Use immediately after opening | ### Stability: Accelerated (high temperature) stress test was conducted to support the stability claim of 24 months when stored at 18℃ to 25℃. Heat stressed reagents showed that the ISE Serum Standards and ISE Urine Standards parameters remained within specification. Open-Vial Stability was conducted to support the claim of 30 days at 18-25℃. Open-vial reagents showed that the ISE Serum Standards and ISE Urine Standards parameters remained within specification. Real time stability studies are in progress and will commence at 6 month intervals for 2 years at 18°C and 25°C. The solutions will be tested analytically for the electrolytes using reference methods. Flame Photometry will be used for the Na " and K . Silver/Silver Chloride Titration method is used for the Cl. Functional performance for calibration and control testing will likewise be performed. #### Traceability: All testing for analytes were conducted using Standards gravimetrically prepared from NIST salts. Testing was also conducted using reference methods. | Analyte | Reference Standard Material Used<br>for Determination of Analyte Value | Reference Method Used | |---------|------------------------------------------------------------------------|--------------------------------------| | Na, K | NIST 919b, 918b | IL 943 (Flame Photometry) | | Cl | NIST 919b | SAT-500 Salt Analyzer, (Titrimetric) | ### Value Assignment: Target values were obtained by testing reagents analytically prior to bottling if necessary to meet specifications, and prior to release to stock for distribution. Each ISE Serum Standard High/Low and ISE Urine Standard High/Low is tested for Na *, K *, and CI , pH, conductivity, calibration and QC Control recovery {6}------------------------------------------------ - To assure reagents meet target values and are within the predetermined acceptance criteria reagents are . tested analytically, adjusted if necessary to meet specifications, prior to bottling. Each is tested analytically during the bottling process and prior to release to stock for distribution. - . Six replicates of each sample are tested analytically for the electrolytes using reference methods. Flame Photometry is used for the Na * and K . Silver/Silver Chloride Titration method is used for the Cl . The IL 943 Flame Photometer is used for testing the Na " and the SAT-500 salt analyzer is used for testing the Cl. - . Lot to lot variation is determined by analytically testing new lot vs. previous lot normalized to either an aqueous standard made with corresponding analyte NIST (National Institute of Standards and Technology) material or a known Calibrator. ## Diamond ISE Serum Standard High/Low and ISE Urine Standard High/Low for ADVIA Chemistry Systems Target values: | ISE Serum Standard Low | Units | Target<br>Value | |------------------------|--------|-----------------| | Na+ | mmol/L | $130 \pm 2$ | | K+ | mmol/L | $3.5 \pm 0.05$ | | Cl- | mmol/L | $85 \pm 2$ | | ISE Serum Standard High | Units | Target<br>Value | |-------------------------|--------|-----------------| | Na+ | mmol/L | 160 +/- 2 | | K+ | mmol/L | 6 +/- 0.05 | | Cl- | mmol/L | 120 +/- 2 | | ISE Urine Standard Low | Units | Target<br>Value | |------------------------|--------|-----------------| | Na+ | mmol/L | $50 +/- 2$ | | K+ | mmol/L | $10 +/- 0.2$ | | Cl- | mmol/L | $50 +/- 2$ | {7}------------------------------------------------ | ISE Urine Standard High | Units | Target<br>Value | |-------------------------|--------|-----------------| | Na+ | mmol/L | 200 +/- 3 | | K+ | mmol/L | 100 +/- 2 | | Cl- | mmol/L | 180 +/- 2 | # Specific Standards and Concentrations used | Analyte | Standard | Concentration<br>(mmol/L) | |---------|-----------|---------------------------| | Na T | NIST 919b | 160, 140, 100, and 50 | | Kt | NIST 918b | 100, 8, 5 and 0.5 | | Cli | NIST 919b | 200, 125, 80, and 5 | The target values were chosen to match the ADVIA ISE Serum Standards and ISE Urine Standards predicate. #### Conclusion: Based on the results submitted in this premarket notification Diamond Diagnostics ISE Serum Standards and ISE Urine Standards for Advia Chemistry systems are substantially equivalent to the Diamond Diagnostics ATAC 8000/Envoy 500 ISE Serum Standards in composition, and Intended use, for the calibration of Na+, K+, and Cl-Electrodes.