(134 days)
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. (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.
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.
Here's a breakdown of the acceptance criteria and study information for the Total Protein Urine/CSF Gen. 3 device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it compares the performance of the modified device (Total Protein Urine/CSF Gen. 3 on COBAS INTEGRA and Roche/Hitachi platforms) against its predicate device (Roche/Hitachi Total Protein Urine/CSF K913615) for various features. The implicit acceptance criterion is "Substantial Equivalence" to the predicate device, meaning the new device performs as well as or better than the predicate for key parameters.
Here's a table summarizing the reported device performance, with the understanding that for most parameters, the 'acceptance' is that the modified device's performance aligns with or improves upon the predicate.
| Feature | Predicate Device Performance (Roche/Hitachi Total Protein Urine/CSF K913615) | Modified Device Performance (Total Protein Urine/CSF Gen. 3) |
|---|---|---|
| Intended Use/Indications for Use | In vitro test for quantitative determination of protein in urine (U) and CSF | Same |
| Specimen | Urine and CSF | Same |
| Application | Endpoint assay | Same |
| Test Principle | Turbidimetric | Same |
| Reagent Composition | R1: Sodium hydroxide 530 mmol/L, EDTA sodium, 74 mmol/L; R2=SR: Benzethonium chloride 32 mmol/L | Same |
| Stability (Shelf-life) | 20-25 °C until expiration date | Roche/Hitachi: 15-25 °C until expiration date |
| Stability (On-board) | R1: 3 weeks on board at 2-12 °C; R2: 3 weeks on board at 2-12 °C | Roche/Hitachi: R1: 21 days on board and refrigerated; R2: 21 days on board and refrigerated 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. | Same |
| Precision (Urine - Within Run) | 2.25% @ 17.9 mg/dL; 0.5% @ 102.2 mg/dL | Roche/Hitachi: 1.9% @ 21 mg/dL; 1.0% @ 67.3 mg/dL COBAS INTEGRA: 2.8%@ 89 mg/L; 1.4% @ 227 mg/L; 0.4% @ 616 mg/L |
| Precision (Urine - Total/Between day) | 3.05% @ 17.9 mg/dL; 0.8% @ 102.2 mg/dL | Roche/Hitachi: 1.7% @ 34.5 mg/dL; 1.1% @ 114.37 mg/dL COBAS INTEGRA: 1.3% @ 91 mg/L; 1.0% @ 229 mg/L; 0.6% @ 613 mg/L |
| Precision (CSF - Within Run) | 3.05% @ 17.9 mg/dL; 0.8% @ 102.2 mg/dL * (Listed as Urine, likely a typo) | Roche/Hitachi: 0.9% @ 23.1 mg/dL; 0.7% @ 53.6 mg/dL COBAS INTEGRA: 0.5% @ 345 mg/L; 0.3% @ 867 mg/L |
| Precision (CSF - Total/Between day) | 1.9% @ 18.1 mg/dL; 1.03% @ 102.4 mg/dL | Roche/Hitachi: 1.0% @ 29.3 mg/dL; 0.6% @ 90.2 mg/dL COBAS INTEGRA: 0.9% @ 346 mg/L; 0.6% @ 867 mg/L |
| Measuring Range (Linearity) | Analyzer specific linearity claims: 2-200 mg/dL (Hitachi 717) | Roche/Hitachi: 2-200 mg/dl (20-2000 mg/l) with dilution capability COBAS INTEGRA: 40-2000 mg/L (Extended to 40-6000 mg/L with post dilution factor of 3) |
| Lower Detection Limit | Not specified | Roche/Hitachi: 20 mg/L COBAS INTEGRA: 40 mg/L |
| Expected Values | Urine 24h: < 150 mg/24 h; CSF: < 150-450 mg/L | Roche/Hitachi: Same COBAS INTEGRA: Same |
| Endogenous Interferences | Reference to Young et al and Friedman et al | Roche/Hitachi: Icterus: No significant interference up to I index of 45 (45 mg/dL bilirubin); Hemolysis: Hemoglobin interferes COBAS INTEGRA Urine: Icterus: No significant interference up to I index of 35 (35 mg/dL bilirubin); Hemolysis: Hemoglobin interferes COBAS INTEGRA CSF: Hemolysis: hemoglobin interferences |
| 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: Levodopa, Methyldopa and Cefoxitin sodium cause interference at therapeutic concentrations. Rare cases of gammopathy (IgM) may cause unreliable results. |
| Method Comparison (Urine) | Hitachi 717 vs. Dupont ACA: y = 1.051x + 2.78, r = 0.996, n = 34 | COBAS INTEGRA 800 vs. Roche/Hitachi 917: Passing/Bablok: y = 1.003x + 2.0 mg/L, τ = 0.951, n = 54 Linear regression: y = 1.007x + 4.2 mg/L, r = 0.999 (Concentrations 40-1989 mg/L) |
| Method Comparison (CSF) | Hitachi 717 vs. Dupont ACA: y = 0.982x - 0.957, r = 0.982, n = 59 | COBAS INTEGRA 800 vs. Roche/Hitachi 917: Passing/Bablok: y = 1.018x + 1.9 mg/L, τ = 0.991, n = 68 Linear regression: y = 1.019x + 2.3 mg/L, r = 1.000 (Concentrations 59-1996 mg/L) |
| 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 Levels | 5 levels: 100, 200, 400, 800, 2000 mg/L | 1 level - 2000 mg/L |
2. Sample Sizes Used for the Test Set and Data Provenance
The document describes method comparison studies for the COBAS INTEGRA platform against the Roche/Hitachi 917 analyzer.
- Urine Test Set: Sample size (n) = 54
- CSF Test Set: Sample size (n) = 68
- Data Provenance: The text does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "human urine and CSF samples," suggesting clinical samples were used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The method comparison relies on comparing the device's measurements against a predicate device's measurements, which are assumed to be "ground truth" for the purpose of demonstrating substantial equivalence. There is no mention of independent experts assessing the "accuracy" of the total protein levels.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth was established by comparison to a predicate device's quantitative measurements, not through subjective expert review and adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC comparative effectiveness study is not relevant for this type of quantitative biochemical assay. This study is about the performance of an automated diagnostic test, not about human readers interpreting images or data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes. The entire study describes the standalone performance of the Total Protein Urine/CSF Gen. 3 reagent on automated COBAS INTEGRA systems. This is a fully automated test system, and its performance characteristics (precision, linearity, detection limit, interference) are assessed in a standalone manner without human intervention in the interpretive process. The "human-in-the-loop" aspect would be a laboratory technician operating the instrument and reporting results, but the analytical performance itself is standalone.
7. The Type of Ground Truth Used
The ground truth for the method comparison studies (the primary study described for the modified device) was established by the measurements from the predicate device (Roche/Hitachi 917 analyzer) using the same reagent. The predicate device itself was "Standardized against National Bureau of Standards Reference Material SRM 927 using the biuret method for the quantitation of protein." This suggests a chain of traceability to a recognized standard.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For an IVD reagent modification submission like this, the focus is typically on validation testing of the final product. Any internal development or training of algorithms (if applicable for such a device, though unlikely for a turbidimetric assay) would be part of the manufacturer's internal design control process and not usually detailed in a 510(k) summary unless explicitly part of the new functionality being validated.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided.
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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 ●
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Total Protein Urine/CSF Gen. 3, Continued
| Submittername, address, contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-4569 | |||
|---|---|---|---|---|
| Contact person: Jennifer Tribbett | ||||
| Date prepared: September 11, 2007 | ||||
| Device Name | Proprietary name: Total Protein Urine/CSF Gen. 3Common name: Total ProteinClassification name: Total Protein test system | |||
| Establishmentregistration | 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 | ClassificationNumber | Classification Name | RegulationCitation | |
| 75 ClinicalChemistry | JGQ | Total Protein test system | 21 CFR 862.1635 | |
| DeviceDescription | 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. |
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:
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| 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. |
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| Feature | Predicate device:Roche/Hitachi Total Protein Urine/CSFK913615 | Modified device:Total Protein Urine/CSF Gen. 3 |
|---|---|---|
| General | ||
| Intended Use/Indications forUse | In vitro test for the quantitativedetermination of protein in urine (U) andcerebrospinal fluid (CSF) | Same |
| Specimen | Urine and CSF | Same |
| Application | Endpoint assay | Same |
| Test Principle | ||
| Referencemethod | Turbidimetric | Same |
| Reagent information | ||
| Reagentcomposition | R1: Sodium hydroxide 530 mmol/L,EDTA sodium, 74 mmol/L | Same |
| R2=SR: Benzethonium chloride 32mmol/L |
Continued on next page
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| Feature | Predicate device:Roche/Hitachi Total Protein Urine/CSFK913615 | Modified device:Total Protein Urine/CSF Gen. 3 |
|---|---|---|
| Stability - shelflife and on-board | 20-25 °C until expiration dateR1: 3 weeks on board at 2-12 °CR2: 3 weeks on board at 2-12 °C | Roche/Hitachi:15-25 °C until expiration dateR1: 21 days on board andrefrigerated on the analyzerR2: 21 days on board andrefrigerated on the analyzerCOBAS INTEGRA 400/400plus: 12 weeks on board at 10to 15°CCOBAS INTEGRA 700/800plus: 6 weeks on board at 10 to15°C |
| Quality control | Commercially available urine and CSFprotein controls | Roche/Hitachi: SameCOBAS INTEGRA:Same |
| Traceability | Standardized against National Bureau ofStandards Reference Material SRM 927using the biuret method for thequantitation of protein. | Same |
| Feature | Predicate device:Roche/Hitachi Total Protein Urine/CSFK913615 | Modified device:Total Protein Urine/CSF Gen. 3 |
| Precision | Urine:Within run (Urine):2.25% @ 17.9 mg/dL0.5% @ 102.2 mg/dLTotal:3.05% @ 17.9 mg/dL0.8% @ 102.2 mg/dLCSF:Within run (Urine):3.05% @ 17.9 mg/dL0.8% @ 102.2 mg/dLTotal:1.9% @ 18.1 mg/dL1.03% @ 102.4 mg/dL | Roche/Hitachi:UrineWithin run:1.9% @ 21 mg/dL1.0% @ 67.3 mg/dLBetween day:1.7% @ 34.5 mg/dL1.1% @ 114.37 mg/dLCSF:Within run:0.9% @ 23.1 mg/dL0.7% @ 53.6 mg/dLBetween day:1.0% @ 29.3 mg/dL0.6% @ 90.2 mg/dLCOBAS INTEGRA:UrineWithin run:2.8%@ 89 mg/L1.4% @ 227 mg/L0.4% @ 616 mg/LBetween day:1.3% @ 91 mg/L1.0% @ 229 mg/L0.6% @ 613 mg/LCSF:Within run:0.5% @ 345 mg/L0.3% @ 867 mg/LBetween day:0.9% @ 346 mg/L0.6% @ 867 mg/L |
| Feature | Predicate device:Roche/Hitachi Total Protein Urine/CSFK913615 | Modified device:Total Protein Urine/CSF Gen. 3 |
| Measuringrange | Analyzer specific linearity claims2-200 mg/dL (Hitachi 717) | Roche/Hitachi:2-200 mg/dl (20-2000 mg/l)Specimen dilutionDetermine samples with U/CSFprotein concentrations > 200mg/dl (2000 mg/l) via the rerunfunction. On instruments withoutrerun function, manually dilutesamples with 0.9% NaCl. Multiplythe result by the appropriatedilution factor.COBAS INTEGRA:40-2000 mg/LExtended measuring range:40-6000 mg/L with post dilutionfactor of 3 recommended |
| Lowerdetection limit | Not specified | Roche/Hitachi:20 mg/LCOBAS INTEGRA: 40 mg/L |
| Expectedvalues(literaturereference) | Urine 24h: < 150 mg/24 hCSF: < 150-450 mg/L | Roche/Hitachi: SameCOBAS INTEGRA:Same |
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Substantial equivalency – Similarities
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Substantial equivalency – Similarities (continued)
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Substantial equivalency – Similarities (continued)
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| Feature | Predicate device:Roche/Hitachi Total Protein Urine/CSFK913615 | Modified device:Total Protein Urine/CSF Gen. 3 |
|---|---|---|
| Endogenousinterferences | Reference to Young et aland Friedman et al | Roche/Hitachi:Icterus: No significantinterference up to an I index of45 (approximate conjugatedand unconjugated bilirubinconcentration: 45 mg/dL).Hemolysis: Hemoglobininterferes.COBAS INTEGRA:UrineIcterus No significantinterference up to an I indexof 35 (approximate conjugatedbilirubin concentration: 599µmol/L or 35 mg/dL).Hemolysis Hemoglobininterferes.CSF:Hemolysis: hemoglobininterferences |
Substantial equivalency – Similarities (continued)
Continued on next page
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| Feature | Predicate device:Roche/Hitachi Total Protein Urine/CSFK913615 | Modified device:Total Protein Urine/CSF Gen. 3 |
|---|---|---|
| Exogenousinterferences | 15 drugs test - no interferences | Hitachi/Roche:No significant interferencefrom:Ascorbic Acid, Creatinine,Glucose,Phosphorus, Urea, Magnesium,Sodium Citrate, Caffeine,Cefazolin Sodium,Chlorpromazine, Calcium L-Dopa, Gentamicin Sulfate,Sodium Oxalate and Uric AcidCOBAS INTEGRA:Of the drugs tested in vitro,Levodopa, Methyldopa andCefoxitin sodium causeinterference at therapeuticconcentrations (artificially hightotal protein levels).In very rare cases gammopathy,in particular type IgM(Waldenstrom'smacroglobulinemia) may causeunreliable results |
| Feature | Predicate device:Roche/Hitachi Total Protein Urine/CSFK913615 | Modified device:Total Protein Urine/CSF Gen. 3 |
| Methodcomparison | A comparison of this method on theHitachi 717 analyzer using the DupontACA method as a reference resulted in thefollowing linear regression statistics: | COBAS INTEGRA 800:Total protein values for humanurine and CSF samples obtainedon a COBAS INTEGRA 800analyzer with the COBASINTEGRA Total ProteinUrine/CSF Gen.3 reagent andC.f.a.s. TPUC 200 calibrator werecompared with those determinedusing the same reagent on aRoche/Hitachi 917 analyzer. |
| Urine:$y= 1.051x +2.78$$r = 0.996$$n=34$ | vs. 917UrineSample size (n) = 54Passing/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 werebetween 40 and 1989 mg/L. | |
| CSFSample size (n) = 68Passing/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 werebetween 59 and 1996 mg/L. | ||
| Feature | Predicate device:Roche/Hitachi Total ProteinUrine/CSF K913615 | Modified device:Total Protein Urine/CSF Gen. 3 |
| Instrumentplatforms | Roche/Hitachi analyzers | Roche/Hitachi family of analyzersand COBAS INTEGRA family ofanalyzers |
| Calibrator | Preciset U/CSF | Roche/Hitachi: SameCOBAS INTEGRA:C.f.a.s. TPUC 200 |
| Calibratorcomposition | 62.5% albumin and 37.5% globulin | Same |
| Stability -shelf-life andon-board | Shelf-life – 2-8 C until expiry4 weeks at 2-8 C after opening | Same |
| Traceability | NIST SRM 972 | Same |
| Levels | 5 levels: 100, 200, 400, 800, 2000mg/L | 1 level - 2000 mg/L |
Substantial equivalency - Similarities (continued)
Continued on next page
September 11, 2007
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510(k) Summary - Total Protein Urine/CSF Gen. 3,
Continued
Substantial equivalency - Similarities (continued)
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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.
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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
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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).
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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
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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)
§ 862.1635 Total protein test system.
(a)
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.(b)
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.