GLUCOSE HK NEW FORMULATION TEST SYSTEM

{0} K062239 SEP 11 2006 # 510(k) Summary – COBAS INTEGRA Glucose HK Gen. 3 ## Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. ## Submitter name, address, contact Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 (317) 521-3723 Contact person: Theresa (Tracy) Ambrose Bush Date prepared: ## Device Name Proprietary name: COBAS INTEGRA Glucose HK New Formulation Common name: Gluc2 Classification name: Glucose Test System ## Device Description The cassette COBAS INTEGRA Glucose HK New Formulation contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF). The test principle is an enzymatic reference method with hexokinase. ## Intended use In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems. ## Predicate Device We claim substantial equivalence to the COBAS INTEGRA Glucose HK Liquid cleared as K972250. ## Substantial equivalency – Similarities The table below indicates the similarities between the modified COBAS INTEGRA Glucose HK New Formulation test and its predicate device (COBAS INTEGRA Glucose HK Liquid, K972250). {1} | Feature | Predicate device: Glucose HK Liquid (K972250) | Modified device: Glucose HK New formulation | | --- | --- | --- | | General | | | | Intended Use/Indications for Use | The cassette COBAS INTEGRA Glucose HK Liquid contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of glucose concentration in serum, plasma, urine and cerebrospinal fluid (CSF). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia. | In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia. | | Specimen type | Serum, plasma, urine, CSF | Same | | Test principle | | | | Reference method | Enzymatic reference method with hexokinase. | Same | | Reagent information | | | | Stability - shelf life and on-board | 2-8 °C until expiration date COBAS INTEGRA 400 8 weeks at 10 to 15°C COBAS INTEGRA 700/800 8 weeks at 8°C | Same | | Calibrator | Calibrator f.a.s. Interval: each lot | Same | | Quality control | Serum and plasma: Precinorm U and Precinorm U Plus Precipath U and Precipath U Plus Urine: Quantitative urine controls CSF: Quantitative CSF controls Interval: 24 hrs recommended | Same | | Traceability | Standardized against Isotope Dilution Mass Spectrometry | Same | | Performance characteristics | | | {2} | Measuring range | 0-40 mmol/L (0-720 mg/dL) Extended measuring range with recommended post dilution factor of 10: 0-400 mmol/L (0-7200 mg/dL) | 0-40 mmol/L (0-720 mg/dL) Extended measuring range with recommended post dilution factor of 10: 0 -400 mmol/L (0-7200 mg/dL) | | --- | --- | --- | | Expected values (literature reference) Additional values are referenced in the method sheet | Plasma (fasting): 3.88-6.38 mmol/L Urine: 1^{st} morning urine 0.3-1.1 mmol/L 24 h urine 0.11-0.50 mmol/24h Serum/plasma: Adults 4.11-5.89 mmol/L | Plasma (fasting): 3.88-6.38 mmol/L Urine: 1^{st} morning urine 0.3-1.1 mmol/L 24 h urine 0.3-0.96 mmol/L Same | | Endogenous interferences | Hemolysis no significant interferences Icterus no significant interferences Lipemia no significant interferences | Same | ## Substantial equivalency – Differences The table below indicates the similarities between the modified COBAS INTEGRA Glucose HK New Formulation test and its predicate device (COBAS INTEGRA Glucose HK Liquid, K972250). | Feature | Predicate device: Glucose HK Liquid (K972250) | Modified device: Glucose HK New Formulation | | --- | --- | --- | | Reagent information | | | | R1 R2 | Mono reagent in vial A and B (liquid) 100 mmol/L MOPS, 12 mmol/L ATP, 6 mmol/L NAD⁺, 10 mmol/L Mg²⁺, =50 μcat/L HK(yeast), =50 μcat/L G6PDH (microbial), 0.09% Sodium azide, pH 7.1 | R1: 100 mmol/L TRIS, 1.7 mmol/L ATP, 4 mmol/L Mg²⁺, 1 mmol/L NADP, pH 7.8 | | | | R2: 4.0 mmol/L Mg²⁺, 30 mmol/L HEPES, =130 μcat/L HK (yeast), =250 μcat/L G6PDH (microbial), pH 7.0 | | Performance characteristics | | | {3} | Precision | Serum and plasma: Within run: 1.7% @ 5.3 mmol/L 0.72% @ 33.2 mmol/L Between run: 2.6% @ 5.3 mmol/L 1.5% @ 33.2 mmol/L Urine application Within run: 1.7% @ 1.7 mmol/L 1.8% @ 37.1 mmol/L Between run: 4.3% @ 1.7 mmol/L 2.9% @ 37.1 mmol/L CSF application Within run: 1.6% @ 1.7 mmol/L 1.8% @ 3.3 mmol/L Between run: 2.3% @ 1.7 mmol/L 1.9% @ 3.3 mmol/L | Serum and plasma: Within run CV%: 1.8 % @ 4.54 mmol/L 1.6% @ 13.5 mmol/L Between run: 2.1% @ 4.54 mmol/L 2.0% @ 13.5 mmol/L Urine application Within run: 1.2% @ 1.63 mmol/L 1.1% @ 16.3 mmol/L Between day: 1.2% @ 1.63 mmol/L 1.1% @ 16.3 mmol/L CSF application Within run: 0.87% @ 3.43 mmol/L 1.3% @ 1.72 mmol/L Between run: 0.91% @ 3.43 mmol/L 1.4% @ 1.72 mmol/L | | --- | --- | --- | | Lower detection limit | Serum and plasma: 0.033 mmol/L Urine application: 0.22 mmol/L CSF application: 0.023 mmol/L | Serum, plasma, urine and CSF: 0.03 mmol/L | | Exogenous Interferences | Falsely low results may be caused by elevated pyruvates levels Gammopathy, in particular IgM, may cause unreliable results in rare cases | In rare cases gammopathy, in particular type IgM (Waldenstrom’s macroglobulinemia) may cause unreliable results. | {4} ## Proposed Labeling Proposed labeling sufficient to describe the device, its intended use, and the directions for use can be found in Section V. We believe the proposed version of the device labeling presented contains all of the technical information required per 21 CFR 809.10. ## Validation and Design Control Development activities were conducted under appropriate design control procedures and the overall product specifications were met. The Declaration of Conformity with Design Controls and Results of Risk Analysis are provided in Section 5.1. Analytical Performance. ## Confidentiality Roche Diagnostics Corporation requests that the FDA not disclose the nature or existence of this submission until the substantial equivalence decision has been reached. ## Closing Modification of the COBAS INTEGRA Glucose HK assay, resulting in the Glucose HK New Formulation assay, did not affect the intended use or indications for use of the device as described in the labeling, nor did it alter the fundamental scientific technology of the device. Therefore, we trust the information provided in this Special 510(k) will support a decision of substantial equivalence of the COBAS INTEGRA Glucose HK Gen.3 to the predicate. If you have any questions or require further information, please do not hesitate to contact this office. - Phone: (317) 521-3723 - FAX: (317) 521-2324 - email: tracy.bush@roche.com {5} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Theresa Abrose Bush Roche Diagnostics 9115 Hague Rd. Indianapolis, IN 46250 SEP 11 2006 Re: k062239 Trade/Device Name: Glucose HK New Formulation (Gluc2) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: August 1, 2006 Received: August 2, 2006 Dear Ms. Abrose Bush: 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {6} Page 2 – 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 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, Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {7} # Indications for Use 510(k) Number (if known): Device Name: Glucose HK New Formulation (Gluc2) Indications For Use: In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia. Prescription Use XXXX (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 In Vitro Diagnostic Devices (OIVD)  Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K062239