Who is the manufacturer of TOTAL PROTEIN URINE/CSF GEN.3?

Roche Diagnostics filed the 510(k) submission for TOTAL PROTEIN URINE/CSF GEN.3 (K071239).

What is the FDA product code for TOTAL PROTEIN URINE/CSF GEN.3?

JGQ. It is classified under 21 CFR 862.1635 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for TOTAL PROTEIN URINE/CSF GEN.3?

510(k) clearance (submission type: Special).

What are the predicate devices for TOTAL PROTEIN URINE/CSF GEN.3?

Roche/Hitachi Total Protein Urine/CSF (K913615).

Who can help prepare an FDA 510(k) submission like TOTAL PROTEIN URINE/CSF GEN.3?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TOTAL PROTEIN URINE/CSF GEN.3

K071239 · Roche Diagnostics · JGQ · Sep 14, 2007 · Clinical Chemistry

Device Facts

Record ID	K071239
Device Name	TOTAL PROTEIN URINE/CSF GEN.3
Applicant	Roche Diagnostics
Product Code	JGQ · Clinical Chemistry
Decision Date	Sep 14, 2007
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1635
Device Class	Class 2

Intended Use

The Urinary/CSF Protein reagent is intended for the quantitative determination of total protein in human urine and cerebrospinal fluid (CSF) on the COBAS Integra 400/700/800 analyzers.

Device Story

In vitro diagnostic reagent for quantitative protein measurement in urine and CSF; utilizes turbidimetric endpoint assay; operates on COBAS INTEGRA and Roche/Hitachi analyzer platforms. Input: patient urine or CSF samples; Output: protein concentration (mg/dL or mg/L). Used in clinical laboratories by trained technicians. Results assist physicians in diagnosing renal, heart, thyroid, and CNS disorders. Benefits include automated, standardized protein quantification for clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm performance of the modified reagent application and automated dilution system.

Technological Characteristics

Turbidimetric endpoint assay. Reagents: R1 (Sodium hydroxide 530 mmol/L, EDTA sodium 74 mmol/L), R2 (Benzethonium chloride 32 mmol/L). Traceable to NIST SRM 927. Automated analyzer-based. Measuring range: 40-2000 mg/L (extended to 6000 mg/L).

Indications for Use

Indicated for quantitative determination of total protein in urine and CSF to aid in diagnosis/treatment of renal, heart, thyroid, liver, kidney, bone marrow, metabolic, or nutritional disorders, and CNS infections/tumors. For prescription use.

Regulatory Classification

Identification

A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

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 § 862.9.

Predicate Devices

Roche/Hitachi Total Protein Urine/CSF (K913615)

Related Devices

K072638 — ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 · Roche Diagnostics Corp. · Oct 19, 2007
K981295 — UPRO · Abbott Laboratories · Oct 1, 1998
K981682 — UPRO · Abbott Laboratories · Sep 21, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ # 11336 510(k) Summary - Total Protein Urine/CSF Gen. 3 Introduction and purpose of submission Roche Diagnostics Corporation hereby submits this Special 510(k): Device Modification to provide notification of modifications to our Total Protein Urine /CSF (TPUC) test system. The reagent was originally cleared for use as: Roche Hitachi Urinary/CSF Protein via K913615. The modification that triggered the need for this filing was the development of a new application of the TPUC reagent to the COBAS INTEGRA family of analyzers, which featured a new calibrator (C.f.a.s. TPUC 200). This application did not meet all of its predetermined acceptance criteria and therefore did not qualify for Internal Documentation under the Reagent Replacement Policy. Since the original clearance of the test system under K913615, other modifications have occurred, which have not themselves resulted in the need for a new submission. These modifications include: - Application of reagent to new members of the Roche/Hitachi family . as those family members have been introduced - . Development of a new application for the Roche/Hitachi family member cobas c501 platform and that included the 'new' calibrator C.f.a.s TPUC 200, which is simply a single level of the originally cleared Preciset U/CSF Calibrator - Other editorial labeling changes ● {1}------------------------------------------------ ## Total Protein Urine/CSF Gen. 3, Continued | Submitter name, address, contact | Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 (317) 521-4569 | | | | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------------------------|------------------------| | | Contact person: Jennifer Tribbett | | | | | | Date prepared: September 11, 2007 | | | | | Device Name | Proprietary name: Total Protein Urine/CSF Gen. 3 Common name: Total Protein Classification name: Total Protein test system | | | | | Establishment registration | The establishment registration number for Roche Diagnostics Gmbh Penzberg is 9610529. The establishment registration number for Roche Diagnostics Corporation Indianapolis is 1823260. | | | | | Classification | The FDA has classified Total protein test system in Class II. | | | | | | Panel | Classification Number | Classification Name | Regulation Citation | | | 75 Clinical Chemistry | JGQ | Total Protein test system | 21 CFR 862.1635 | | Device Description | The COBAS INTEGRA Total Protein Urine/SCG Gen. 3 reagent is intended for use on the COBAS INTEGRA systems for the quantitative determination of protein in urine and cerebrospinal fluid. | | | | Continued on next page : {2}------------------------------------------------ | Intended use and Summary | TOTAL PROTEIN URINE / CSF Gen 3. | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Intended Use: In vitro diagnostic test intended for the quantitative determination of the total protein concentration in urine and cerebrospinal fluid on COBAS INTEGRA systems. | | | Summary: Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by preteinuria or albuminuria. | | | CSF protein measurements are used in diagnosis and treatment of disease conditions such as meningitis, brain tumors and infections of the central nervous systems. C.f.a.s. TPUC 200 C.f.a.s. (Calibrator for automated systems) TPUC 200 is for use in the calibration of quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) on COBAS INTEGRA analyzers and Roche/Hitachi cobas c systems. | | Predicate Device | We claim substantial equivalence to the Urinary/CSF Protein test system cleared as K913615. | | Substantial equivalency - Similarities | The table below indicates the similarities and differences between the modified Total Protein reagent and the predicate device. | · 3 of 12 {3}------------------------------------------------ | Feature | Predicate device: Roche/Hitachi Total Protein Urine/CSF K913615 | Modified device: Total Protein Urine/CSF Gen. 3 | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | General | | | | Intended Use/ Indications for Use | In vitro test for the quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) | Same | | Specimen | Urine and CSF | Same | | Application | Endpoint assay | Same | | Test Principle | | | | Reference method | Turbidimetric | Same | | Reagent information | | | | Reagent composition | R1: Sodium hydroxide 530 mmol/L, EDTA sodium, 74 mmol/L | Same | | | R2=SR: Benzethonium chloride 32 mmol/L | | Continued on next page ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {4}------------------------------------------------ | Feature | Predicate device: Roche/Hitachi Total Protein Urine/CSF K913615 | Modified device: Total Protein Urine/CSF Gen. 3 | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Stability - shelf life and on-board | 20-25 °C until expiration date R1: 3 weeks on board at 2-12 °C R2: 3 weeks on board at 2-12 °C | Roche/Hitachi: 15-25 °C until expiration date R1: 21 days on board and refrigerated on the analyzer R2: 21 days on board and refrigerated on the analyzer COBAS INTEGRA 400/400 plus: 12 weeks on board at 10 to 15°C COBAS INTEGRA 700/800 plus: 6 weeks on board at 10 to 15°C | | Quality control | Commercially available urine and CSF protein controls | Roche/Hitachi: Same COBAS INTEGRA: Same | | Traceability | Standardized against National Bureau of Standards Reference Material SRM 927 using the biuret method for the quantitation of protein. | Same | | Feature | Predicate device: Roche/Hitachi Total Protein Urine/CSF K913615 | Modified device: Total Protein Urine/CSF Gen. 3 | | Precision | Urine: Within run (Urine): 2.25% @ 17.9 mg/dL 0.5% @ 102.2 mg/dL Total: 3.05% @ 17.9 mg/dL 0.8% @ 102.2 mg/dL CSF: Within run (Urine): 3.05% @ 17.9 mg/dL 0.8% @ 102.2 mg/dL Total: 1.9% @ 18.1 mg/dL 1.03% @ 102.4 mg/dL | Roche/Hitachi: Urine Within run: 1.9% @ 21 mg/dL 1.0% @ 67.3 mg/dL Between day: 1.7% @ 34.5 mg/dL 1.1% @ 114.37 mg/dL CSF: Within run: 0.9% @ 23.1 mg/dL 0.7% @ 53.6 mg/dL Between day: 1.0% @ 29.3 mg/dL 0.6% @ 90.2 mg/dL COBAS INTEGRA: Urine Within run: 2.8%@ 89 mg/L 1.4% @ 227 mg/L 0.4% @ 616 mg/L Between day: 1.3% @ 91 mg/L 1.0% @ 229 mg/L 0.6% @ 613 mg/L CSF: Within run: 0.5% @ 345 mg/L 0.3% @ 867 mg/L Between day: 0.9% @ 346 mg/L 0.6% @ 867 mg/L | | Feature | Predicate device: Roche/Hitachi Total Protein Urine/CSF K913615 | Modified device: Total Protein Urine/CSF Gen. 3 | | Measuring range | Analyzer specific linearity claims 2-200 mg/dL (Hitachi 717) | Roche/Hitachi: 2-200 mg/dl (20-2000 mg/l) Specimen dilution Determine samples with U/CSF protein concentrations > 200 mg/dl (2000 mg/l) via the rerun function. On instruments without rerun function, manually dilute samples with 0.9% NaCl. Multiply the result by the appropriate dilution factor. COBAS INTEGRA: 40-2000 mg/L Extended measuring range: 40-6000 mg/L with post dilution factor of 3 recommended | | Lower detection limit | Not specified | Roche/Hitachi: 20 mg/L COBAS INTEGRA: 40 mg/L | | Expected values (literature reference) | Urine 24h: < 150 mg/24 h CSF: < 150-450 mg/L | Roche/Hitachi: Same COBAS INTEGRA: Same | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ---- .. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ #### Substantial equivalency – Similarities Continued on next page ------ - - ------------------------------------------------------------------------------------------------------------------------------------------------------------------- {5}------------------------------------------------ Substantial equivalency – Similarities (continued) {6}------------------------------------------------ #### Substantial equivalency – Similarities (continued) Continued on next page ・ {7}------------------------------------------------ | Feature | Predicate device: Roche/Hitachi Total Protein Urine/CSF K913615 | Modified device: Total Protein Urine/CSF Gen. 3 | |-----------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Endogenous interferences | Reference to Young et al and Friedman et al | Roche/Hitachi: Icterus: No significant interference up to an I index of 45 (approximate conjugated and unconjugated bilirubin concentration: 45 mg/dL). Hemolysis: Hemoglobin interferes. COBAS INTEGRA: Urine Icterus No significant interference up to an I index of 35 (approximate conjugated bilirubin concentration: 599 µmol/L or 35 mg/dL). Hemolysis Hemoglobin interferes. CSF: Hemolysis: hemoglobin interferences | #### Substantial equivalency – Similarities (continued) Continued on next page . {8}------------------------------------------------ | Feature | Predicate device: Roche/Hitachi Total Protein Urine/CSF K913615 | Modified device: Total Protein Urine/CSF Gen. 3 | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Exogenous interferences | 15 drugs test - no interferences | Hitachi/Roche: No significant interference from: Ascorbic Acid, Creatinine, Glucose, Phosphorus, Urea, Magnesium, Sodium Citrate, Caffeine, Cefazolin Sodium, Chlorpromazine, Calcium L- Dopa, Gentamicin Sulfate, Sodium Oxalate and Uric Acid COBAS INTEGRA: Of the drugs tested in vitro, Levodopa, Methyldopa and Cefoxitin sodium cause interference at therapeutic concentrations (artificially high total protein levels). In very rare cases gammopathy, in particular type IgM (Waldenstrom's macroglobulinemia) may cause unreliable results | | Feature | Predicate device: Roche/Hitachi Total Protein Urine/CSF K913615 | Modified device: Total Protein Urine/CSF Gen. 3 | | Method comparison | A comparison of this method on the Hitachi 717 analyzer using the Dupont ACA method as a reference resulted in the following linear regression statistics: | COBAS INTEGRA 800: Total protein values for human urine and CSF samples obtained on a COBAS INTEGRA 800 analyzer with the COBAS INTEGRA Total Protein Urine/CSF Gen.3 reagent and C.f.a.s. TPUC 200 calibrator were compared with those determined using the same reagent on a Roche/Hitachi 917 analyzer. | | | Urine: $y= 1.051x +2.78$ $r = 0.996$ $n=34$ | vs. 917 Urine Sample size (n) = 54 Passing/Bablok $y = 1.003x + 2.0$ mg/L $\tau = 0.951$ | | | CSF: $y = 0.982x - 0.957$ $r = 0.982$ $n=59$ | Linear regression $y = 1.007x + 4.2$ mg/L $r = 0.999$ The sample concentrations were between 40 and 1989 mg/L. | | | | CSF Sample size (n) = 68 Passing/Bablok $y=1.018x + 1.9$ mg/L $\tau = 0.991$ | | | | Linear regression $y =1.019x + 2.3$ mg/L $r = 1.000$ The sample concentrations were between 59 and 1996 mg/L. | | Feature | Predicate device: Roche/Hitachi Total Protein Urine/CSF K913615 | Modified device: Total Protein Urine/CSF Gen. 3 | | Instrument platforms | Roche/Hitachi analyzers | Roche/Hitachi family of analyzers and COBAS INTEGRA family of analyzers | | Calibrator | Preciset U/CSF | Roche/Hitachi: Same COBAS INTEGRA: C.f.a.s. TPUC 200 | | Calibrator composition | 62.5% albumin and 37.5% globulin | Same | | Stability - shelf-life and on-board | Shelf-life – 2-8 C until expiry 4 weeks at 2-8 C after opening | Same | | Traceability | NIST SRM 972 | Same | | Levels | 5 levels: 100, 200, 400, 800, 2000 mg/L | 1 level - 2000 mg/L | #### Substantial equivalency - Similarities (continued) Continued on next page September 11, 2007 :: {9}------------------------------------------------ # 510(k) Summary - Total Protein Urine/CSF Gen. 3, Continued #### Substantial equivalency - Similarities (continued) {10}------------------------------------------------ ### 510(k) Summary - Total Protein Urine/CSF Gen. 3, Continued The table below indicates the differences between the modified Protein direct Substantial Differences or total reagents and their predicate devices. Proposed labeling sufficient to describe the device, its intended use, and the Proposed Labeling directions for use care included. We believe the proposed version of the device labeling presented contains all of the technical information required per 21 CFR 809.10. Also, Roche/Hitachi and COBAS INTEGRA labeling is included in this submission for purpose of CLIA categorization. Validation and Development activities were conducted under appropriate design control procedures and the overall product specifications were met. The Declaration Design Control of Conformity with Design Controls and Results of Risk Analysis are provided. {11}------------------------------------------------ Modification of the Total Protein Urine/CSF reagent does not affect the Closing intended use or indications for use of the device as described in the labeling, nor does it alter the fundamental scientific technology of the device. Therefore, we trust the information provided in this 510(k) will support a decision of substantial equivalence of the Total Protein Urine/CSF Gen. 3 to its predicate. > If you have any questions or require further information, please do not hesitate to contact this office. - Phone: (317) 521-4569 - · FAX: (317) 521-2324 - · email: jennifer.tribbett@roche.com {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Druq Administration 2098 Gaither Road Rockville MD 20850 Roche Diagnostics c\o Ms. Jennifer Tribbet Regulatory Principal 9155 Hague Rd. PO BOX 50416 Indianopolis, IN 46250 SEP 1 4 2007 k071239 Re: Trade Name: Total Protein Urine/CSF Gen. Test System Regulation Number: 21 CFR 862.1635 Regulation Name: Total Protein test system Regulatory Class: Class II Product Code: JGQ, JIX Dated: August 16, 2007 Received: August 17, 2007 Dear Ms. Tribbet: 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). {13}------------------------------------------------ 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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Jean M. Cooper, M.S., D.V.M. Yean M. Cooper, M.S., 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 {14}------------------------------------------------ #### Indication for Use 510(k) Number (if known): K071239 #### Device Name: Total Protein Urine/CSF Gen. Test System Indication For Use: #### TOTAL PROTEIN URINE / CSF Gen 3. In vitro test for the quantitative determination of the total protein in urine and cerebrospinal fluid on the COABS INTEGRA systems. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidnev or bone marrow as well as metabolic or nutritional disorders. Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria. CSF protein measurements are used in diagnosis and treatment of disease conditions such as meningitis, brain tumors and infections of the central nervous systems. #### C.f.a.s. TPUC 200 C.f.a.s. (Calibrator for automated systems) TPUC 200 is for use in the calibration of quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) on COBAS INTEGRA analyzers and Roche/Hitachi cobas c systems. Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD) Carol C Benson Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)

TOTAL PROTEIN URINE/CSF GEN.3

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TOTAL PROTEIN URINE/CSF GEN.3

Device Facts

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Device Story

Clinical Evidence

Technological Characteristics

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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