Who is the manufacturer of ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801?

Roche Diagnostics Corp. filed the 510(k) submission for ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (K072638).

What is the FDA product code for ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801?

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 ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801?

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

What are the predicate devices for ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801?

Roche/Hitachi Urinary/CSF Protein (K913615).

Who can help prepare an FDA 510(k) submission like ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801?

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.

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

K072638 · Roche Diagnostics Corp. · JGQ · Oct 19, 2007 · Clinical Chemistry

Device Facts

Record ID	K072638
Device Name	ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
Applicant	Roche Diagnostics Corp.
Product Code	JGQ · Clinical Chemistry
Decision Date	Oct 19, 2007
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1635
Device Class	Class 2

Intended Use

The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.

Device Story

In vitro diagnostic reagent for quantitative total protein measurement in urine and CSF; used on Roche/Hitachi analyzers. Modification introduces kinetic (rate) assay method alongside existing endpoint assay. Device processes patient samples via automated analyzer; measures protein concentration; provides quantitative results to clinicians for diagnostic assessment. Operates in clinical laboratory settings; managed by laboratory technicians/pathologists. Output informs clinical decision-making regarding renal function or neurological status.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm performance of the new kinetic assay method against established acceptance criteria.

Technological Characteristics

Turbidimetric assay; Reagent R1: Sodium hydroxide (530 mmol/L), EDTA sodium (74 mmol/L); Reagent R2: Benzethonium chloride (32 mmol/L). Automated clinical chemistry analyzer platform. Measuring range: 6-200 mg/dL (rate assay). Standardized against National Bureau of Standards SRM 927a (biuret method).

Indications for Use

Indicated for quantitative protein determination in urine and cerebrospinal fluid to aid in the diagnosis and treatment of diseases involving the liver, kidney, bone marrow, metabolic or nutritional disorders, renal or heart diseases, thyroid disorders, meningitis, brain tumors, and central nervous system infections.

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 Urinary/CSF Protein (K913615)

Related Devices

K071239 — TOTAL PROTEIN URINE/CSF GEN.3 · Roche Diagnostics · Sep 14, 2007
K981295 — UPRO · Abbott Laboratories · Oct 1, 1998
K981682 — UPRO · Abbott Laboratories · Sep 21, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ K072638 OCT 1 9 2007 # 510(k) Summary - Roche/Hitachi Urinary/CSF Protein Introduction and purpose of submission Roche Diagnostics Corporation hereby submits this Special 510(k): Device Modification to provide notification of modifications to our Urine/CSF Protein test system. The reagent was originally cleared as an endpoint, turbidimetric assay for use as Roche/Hitachi Urinary/CSF Protein via K913615. Subsequent to this filing, a rate (kinetic) application was developed, in addition to the original endpoint assay, and applied to the Hitachi family of analyzers. This additional rate application did not involve any changes to the reagent formulation, and is the sole purpose of this Special 510(k). {1}------------------------------------------------ # 510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued | Submitter name, address, contact | Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 (317) 521-7637 Contact person: Kerwin Kaufman Date prepared: September 17, 2007 | | | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------------------------|------------------------| | Device Name | Proprietary name: Roche/Hitachi Urinary/CSF Protein Common name: Total Protein Classification name: Total Protein test system | | | | | 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 | | Establishment registration | The establishment registration number for Roche Diagnostics GmbH Penzberg is 9610529. The establishment registration number for Roche Diagnostics Corporation Indianapolis is 1823260. | | | | | Device Description | The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. The modified device includes both the original endpoint assay and the additional rate assay. The new rate assay was developed to provide absorbance limits that will flag high protein samples with high absorbance, thus eliminating the need for prescreening samples for high protein levels. The endpoint assay still requires sample prescreening or inspection of the Reaction Monitor display after completion of the reaction to ensure that high samples are detected and appropriately diluted for rerun. The attached labeling provides a more complete description of this potential high sample / prozone effect. | | | | {2}------------------------------------------------ # 510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued | Intended use and Summary | Intended Use The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 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 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. | | Predicate Device | We claim substantial equivalence to the Hitachi Urinary/CSF Protein test system cleared as K913615. | | Substantial equivalency – Similarities | The table below indicates the similarities and differences between the modified Urinary/CSF Protein reagent and the predicate device. | {3}------------------------------------------------ # 510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued | Feature | Predicate device: Roche/Hitachi Urinary/CSF Protein K913615 | Modified device: Roche/Hitachi Urinary/CSF Protein, Additional RATE Application | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | | | | Intended Use | For the quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF). | In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. | | Specimen | Urine and CSF | Same | | Application | Endpoint assay | Endpoint and Rate application | | Instrument Platforms | Roche/Hitachi analyzers | Same | | Test Principle | | | | Reference method | Turbidimetric | Same | | Reagent information | | | | Reagent composition | R1: Sodium hydroxide 530 mmol/L, EDTA sodium, 74 mmol/L R2: Benzethonium chloride 32 mmol/L | Same | | 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 | 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 | | Calibrator | Preciset U/CSF Protein 5 levels: 10, 20, 40, 80, 200 mg/dL 0.9 % NaCl used for a 0 mg/dL level | Same | | Quality control | Commercially available urine and CSF protein controls | Same | | Traceability | This method has been standardized against the National Bureau of Standards Reference Material SRM 927a using the biuret method for the quantitation of protein | Same | {4}------------------------------------------------ # 510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued | Feature | Predicate device: Roche/Hitachi Urinary/CSF Protein K913615 | | | Modified device: Roche/Hitachi Urinary/CSF Protein, Additional RATE Application | | | | | | | | |-----------------------------|-------------------------------------------------------------------|----------------------|-------------|---------------------------------------------------------------------------------------|---------------------|---------------------|----------------------|---------|----------------------|-------------|---------| | Performance characteristics | | | | | | | | | | | | | Precision | Urine: (data from K913615 labeling, page 33) | | | Urine: Within run and Between run: | | | | | | | | | | | Within-run (n = 120) | | | Within-run (n = 21) | | Between-run (n = 10) | | | | | | | Sample | Mean mg/dL | SD mg/dL | CV % | Sample | Mean mg/dL | SD mg/dL | CV % | Mean mg/dL | SD mg/dL | CV % | | | Control 1 | 8.2 | 0.53 | 6.4 | Human urine | 10.0 | 0.52 | 5.2 | 12.0 | 0.46 | 3.8 | | | Control 2 | 22.4 | 0.30 | 1.4 | Control 1 | 21.7 | 0.42 | 1.9 | 34.5 | 0.60 | 1.7 | | | Control 3 | 182.4 | 0.90 | 0.5 | Control 2 | 67.3 | 0.66 | 1.0 | 114.37 | 1.30 | 1.1 | | | | Total (n = 120) | | | | | | | | | | | | Sample | Mean mg/dL | SD mg/dL | CV % | | | | | | | | | | Control 1 | 8.2 | 0.65 | 7.9 | | | | | | | | | | Control 2 | 22.4 | 0.55 | 2.5 | | | | | | | | | | Control 3 | 182.4 | 1.60 | 0.9 | | | | | | | | | | CSF: (data from K913615 labeling, page 33) | | | CSF: Within run and Between run: | | | | | | | | | | | Within-run | | | | | | | | | | | | Sample | Mean mg/dL | SD mg/dL | CV % | | Within-run (n = 20) | | | Between-run (n = 10) | | | | | | | | | Sample | Mean mg/dL | SD mg/dL | CV % | Mean mg/dL | SD mg/dL | CV % | | | Control 1 (n=120) | 11.4 | 0.42 | 3.7 | Control 1 | 23.1 | 0.20 | 0.9 | 29.3 | 0.30 | 1.0 | | | Control 2 (n=119) | 23.8 | 0.31 | 1.3 | Control 2 | 53.6 | 0.36 | 0.7 | 90.2 | 0.56 | 0.6 | | | Control 3 (n=119) | 81.0 | 0.60 | 0.7 | | | | | | | | | | | Total | | | | | | | | | | | | Sample | Mean mg/dL | SD mg/dL | CV % | | | | | | | | | | Control 1 (n=120) | 11.4 | 0.59 | 5.1 | | | | | | | | | | Control 2 (n=119) | 23.8 | 0.49 | 2.0 | | | | | | | | | | Control 3 (n=119) | 81.0 | 0.74 | 0.9 | | | | | | | | ### Substantial equivalency – Similarities Continued on next page : {5}------------------------------------------------ # 510(k) Summary - Roche/Hitachi Urinary/CSF Protein, Continued | Feature | Predicate device: Roche/Hitachi Urinary/CSF Protein K913615 | Modified device: Roche/Hitachi Urinary/CSF Protein, Additional RATE Application | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Measuring range | Endpoint Assay: 2-200 mg/dL | Endpoint Assay: 2-200 mg/dL | | | If results exceed the upper limit of the measuring range, dilute the specimen with isotonic saline and repeat the | Rate Assay: 6-200 mg/dL | | | assay. | 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. | | Lower detection limit | 2 mg/dL | Endpoint Assay: 2 mg/dL | | | | Rate Assay 6 mg/dL | | Expected values (literature reference) | Urine Random: < 12 mg/dL Urine 24h: < 150 mg/day CSF: 15-45 mg/dL | Urine 24h: < 150 mg/day CSF: 15-45 mg/dL | | Endogenous interferences ** | Hemolysis or RBC contamination interferes with the assay | Icterus: No significant interference up to an I index of 36 (approximate conjugated concentration: 36 | | | Reference to Young et al and Friedman et al | mg/dL or 615 µmol/L). Hemolysis: Hemoglobin interferes. | Substantial equivalency – Similarities (continued) ** Data on interferences applies to both the endpoint and the additional rate application {6}------------------------------------------------ # 510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued | Feature | Predicate device: Roche/Hitachi Urinary/CSF Protein K913615 | Modified device: Roche/Hitachi Urinary/CSF Protein, Additional RATE Application | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Exogenous interferences ** | There is no significant interference from the following substances: Ascorbic Acid, Creatinine, Glucose, Phosphorus, Urea, Magnesium, Sodium Citrate, Caffeine, Cefazolin Sodium, Chlorpromazine, Calcium L-Dopa, Gentamicin Sulfate, Sodium Oxalate and Uric Acid | 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 Therapeutic concentrations of Ca-dobesilate, levodopa and phenazopyridine interfere with the assay. The administration of gelatin-based plasma replacements can lead to increased urine protein values. In very rare cases gammopathy, in particular type IgM (Waldenström's macroglobulinemia), may cause unreliable results. | #### Substantial equivalency – Similarities (continued) ** Data on interferences applies to both the endpoint and the additional rate application {7}------------------------------------------------ # 510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued # Substantial equivalency – Similarities (continued) | Feature | Predicate device: Roche/Hitachi Urinary/CSF Protein K913615 | Modified device: Roche/Hitachi Urinary/CSF Protein, Additional RATE Application | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Method comparison | A comparison of this method on the Hitachi 717 analyzer using the DuPont ACA method as the reference resulted in the following linear regression statistics: Urine samples: y= 1.051x +2.78 r = 0.996 n=34 CSF samples: y = 0.992x - 0.957 r = 0.982 n=59 | A comparison of the U/CSF Protein determination with Roche Diagnostics U/CSF Protein reagent using the rate application (y) with the same reagent using the endpoint application (x) gave the following correlations (mg/dL): Urine samples: Passing/Bablok y = 0.988x - 0.434 r = 1.000 Number of samples measured: 60 The sample concentrations were between 1.7 and 3286.5 mg/dL. Statistics include all results (diluted and undiluted). CSF samples: Passing/Bablok y = 0.984x + 0.480 r = 1.000 Number of samples measured: 50 The sample concentrations were between 5.8 and 110.2 mg/dL. | {8}------------------------------------------------ # 510(k) Summary – Roche/Hitachi Urinary/CSF Protein, ______________________________________________________________________________________________________________________________________________________________________________ Continued | Proposed Labeling | Proposed labeling sufficient to describe the device, its intended use, and the directions for use are included. 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. | | | Closing | The modification of the Roche/Hitachi Urinary/CSF Protein reagent described above does not affect the 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 Special 510(k) will support a decision of substantial equivalence of the Roche/Hitachi Urinary/CSF Protein with the Rate application to its predicate. | | | | If you have any questions or require further information, please do not hesitate to contact this office. | | | | Kerwin Kaufman, MBA, MT(ASCP) | | | | Regulatory Affairs Principal Roche Diagnostics • Phone: (317) 521-7637 • FAX: (317) 521-2324 • email: Kerwin.Kaufman@roche.com | | . : {9}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 1 9 2007 Roche Diagnostics Corp. c/o Mr. Kerwin L. Kaufman Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN 46250-0416 Re: k072638 Trade/Device Name: Roche/Hitachi Urinary/CSF Protein Regulation Number: 21 CFR 862.1635 Regulation Name: Total Protein test system. Regulatory Class: Class II Product Code: JGQ Dated: September 17, 2007 Received: September 18, 2007 Dear Mr. Kaufman: 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). {10}------------------------------------------------ #### 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. Jéan 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 {11}------------------------------------------------ # Indications for Use #### K072638 510(k) Number (if known): Device Name: Roche/Hitachi Urinary/CSF Protein Indications For Use: In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. 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 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 conditions such as meningitis, brain tumors and infections of the central nervous systems. Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 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) Carl Benson ision Sign-Off Page 1 of Tice of In Vitro Diagnostic Device Juation and Safety K072638

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

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ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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