(31 days)
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.
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.
Here's an analysis of the provided 510(k) summary regarding the Roche/Hitachi Urinary/CSF Protein test, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) Special Modification submission, which focuses on comparing a modified device (with an added "rate" application) to a predicate device (the original "endpoint" application). Therefore, the "acceptance criteria" discussed are largely implicit in demonstrating substantial equivalence to the predicate, with performance characteristics being compared directly.
| Feature / Criteria | Predicate Device Performance (Endpoint Assay, K913615) | Modified Device Performance (Rate Application) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| 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. | Maintain intended use of predicate. |
| Specimen | Urine and CSF | Same | Same specimen types as predicate. |
| Application | Endpoint assay | Endpoint and Rate application | New rate application should be equivalent to or improve upon endpoint. |
| Measuring Range (Urine) | 2-200 mg/dL | 6-200 mg/dL (Rate Assay) | Equivalent or improved measuring range. |
| Measuring Range (CSF) | 2-200 mg/dL | 6-200 mg/dL (Rate Assay) | Equivalent or improved measuring range. |
| Lower Detection Limit (Urine) | 2 mg/dL | 6 mg/dL (Rate Assay) | Acceptable detection limit for clinical use, comparable to predicate. |
| Lower Detection Limit (CSF) | 2 mg/dL | 6 mg/dL (Rate Assay) | Acceptable detection limit for clinical use, comparable to predicate. |
| Expected Values | 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 | Consistent with accepted clinical reference values. |
| Precision (Urine, Within-run CV%) | Control 1: 6.4%; Control 2: 1.4%; Control 3: 0.5% (n=120) | Human urine: 5.2%; Control 1: 1.9%; Control 2: 1.0% (n=21) | Demonstrate comparable or improved precision. |
| Precision (Urine, Between-run CV%) | Control 1: Not reported; Control 2: Not reported; Control 3: Not reported | Human urine: 3.8%; Control 1: 1.7%; Control 2: 1.1% (n=10) | Demonstrate comparable or improved precision. |
| Precision (CSF, Within-run CV%) | Control 1: 3.7%; Control 2: 1.3%; Control 3: 0.7% (n=120) | Control 1: 0.9%; Control 2: 0.7% (n=20) | Demonstrate comparable or improved precision. |
| Precision (CSF, Between-run CV%) | Control 1: Not reported; Control 2: Not reported; Control 3: Not reported | Control 1: 1.0%; Control 2: 0.6% (n=10) | Demonstrate comparable or improved precision. |
| Method Comparison (Urine) | y= 1.051x +2.78, r = 0.996, n=34 (vs. DuPont ACA) | Passing/Bablok: y = 0.988x - 0.434, r = 1.000, n=60 (vs. Endpoint) | High correlation and agreement with predicate/reference. |
| Method Comparison (CSF) | y = 0.992x - 0.957, r = 0.982, n=59 (vs. DuPont ACA) | Passing/Bablok: y = 0.984x + 0.480, r = 1.000, n=50 (vs. Endpoint) | High correlation and agreement with predicate/reference. |
| Endogenous Interferences | Hemolysis or RBC contamination interferes. | Icterus: No significant interference up to I index of 36. Hemolysis: Hemoglobin interferes. | Similar or improved interference profile. |
| Exogenous Interferences | No significant interference from listed substances. | No significant interference from listed substances. Therapeutic concentrations of Ca-dobesilate, levodopa, phenazopyridine interfere. Gelatin-based plasma replacements increase urine protein. Rare IgM gammopathy interferes. | Similar or improved interference profile. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision:
- Urine:
- Within-run: n=21 (Modified device) compared to n=120 (Predicate device).
- Between-run: n=10 (Modified device).
- CSF:
- Within-run: n=20 (Modified device) compared to n=120/119 (Predicate device).
- Between-run: n=10 (Modified device).
- Urine:
- Method Comparison:
- Urine samples: n=60 (Modified device vs. Endpoint application). Concentrations between 1.7 and 3286.5 mg/dL.
- CSF samples: n=50 (Modified device vs. Endpoint application). Concentrations between 5.8 and 110.2 mg/dL.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific institution, retrospective/prospective). However, the study involves comparisons against an existing, cleared device, implying lab-based performance verification. It is implied to be retrospective analysis of performance characteristics, likely from laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (modification to an in vitro diagnostic test kit) does not typically involve expert review for "ground truth" in the way, for example, an imaging AI device would. The "ground truth" for the performance studies (precision, method comparison) is based on the quantitative results generated by the laboratory instruments themselves, often using reference methods or the predicate device as a comparator. Therefore, this section is not applicable to this type of device.
4. Adjudication Method for the Test Set
As this is a quantitative in vitro diagnostic device, there is no "adjudication method" in the human-centric sense typically applied to image-based AI or complex diagnostic interpretations. The results are numerical values, and their accuracy is assessed against accepted laboratory standards or comparative methods. Therefore, this section is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance
This is an in vitro diagnostic device for laboratory use, not an AI device for interpretation by human readers. Therefore, an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a reagent and an application on an automated clinical chemistry analyzer. The performance characteristics reported (precision, method comparison) represent the standalone performance of this "rate application" on the analyzer. The results are quantitative outputs from the instrument. So, in essence, the performance studies reflect the standalone performance of the modified application.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance studies relied on:
- Reference Methods/Predicate Device: For method comparison, the modified rate application was compared against the original endpoint application (which was previously cleared based on comparison with the DuPont ACA method, standardized against NBS Reference Material SRM 927a using the biuret method).
- Known Concentrations: For precision studies, control materials and human samples with referenceable concentrations (though not explicitly stated whether these were clinically confirmed pathology or outcome data) were used. The controls themselves serve as a form of "ground truth" for expected values.
8. The Sample Size for the Training Set
This is a chemical reagent and an application for an automated analyzer, not a machine learning or AI model that requires a "training set" in the typical sense. The original development of the rate application would have involved optimization and testing, but it's not described as a formal "training set" like in AI. Therefore, this section is not applicable for an AI training set, but the development likely involved numerous samples for internal optimization.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the predicate device's original clearance (K913615, which this modification refers back to) was established by standardizing against the National Bureau of Standards Reference Material SRM 927a using the biuret method for protein quantitation. The current submission demonstrates the equivalence of the modified rate application to this established methodology.
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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).
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510(k) Summary – Roche/Hitachi Urinary/CSF Protein,
Continued
| Submittername, address,contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-7637Contact person: Kerwin KaufmanDate prepared: September 17, 2007 | |||
|---|---|---|---|---|
| Device Name | Proprietary name: Roche/Hitachi Urinary/CSF ProteinCommon name: Total ProteinClassification name: Total Protein test system | |||
| 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 | |
| Establishmentregistration | The establishment registration number for Roche Diagnostics GmbHPenzberg is 9610529.The establishment registration number for Roche Diagnostics CorporationIndianapolis is 1823260. | |||
| DeviceDescription | The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for thequantitative determination of protein in urine and cerebrospinal fluid onRoche automated clinical chemistry analyzers.The modified device includes both the original endpoint assay and theadditional rate assay. The new rate assay was developed to provideabsorbance 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 theReaction Monitor display after completion of the reaction to ensure that highsamples are detected and appropriately diluted for rerun. The attachedlabeling provides a more complete description of this potential high sample /prozone effect. |
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510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued
| Intended useand Summary | Intended UseThe Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for thequantitative determination of protein in urine and cerebrospinal fluid onRoche automated clinical chemistry analyzers. |
|---|---|
| SummaryProtein measurements in urine are used in the diagnosis and treatment ofdisease conditions such as renal or heart diseases, or thyroid disorders, whichare characterized by proteinuria or albuminuria. | |
| CSF protein measurements are used in diagnosis and treatment of diseaseconditions such as meningitis, brain tumors and infections of the centralnervous systems. | |
| PredicateDevice | We claim substantial equivalence to the Hitachi Urinary/CSF Protein testsystem cleared as K913615. |
| Substantialequivalency –Similarities | The table below indicates the similarities and differences between themodified Urinary/CSF Protein reagent and the predicate device. |
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510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued
| Feature | Predicate device:Roche/Hitachi Urinary/CSF ProteinK913615 | Modified device:Roche/Hitachi Urinary/CSFProtein, Additional RATEApplication |
|---|---|---|
| General | ||
| Intended Use | For the quantitative determination ofprotein in urine (U) and cerebrospinalfluid (CSF). | In vitro test for the quantitativedetermination of protein in urineand cerebrospinal fluid on Rocheautomated clinical chemistryanalyzers. |
| Specimen | Urine and CSF | Same |
| Application | Endpoint assay | Endpoint and Rate application |
| InstrumentPlatforms | Roche/Hitachi analyzers | Same |
| Test Principle | ||
| Referencemethod | Turbidimetric | Same |
| Reagent information | ||
| Reagentcomposition | R1: Sodium hydroxide 530 mmol/L,EDTA sodium, 74 mmol/LR2: Benzethonium chloride 32 mmol/L | Same |
| 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 | 15-25 °C until expiration dateR1: 21 days on board andrefrigerated on the analyzerR2: 21 days on board andrefrigerated on the analyzer |
| Calibrator | Preciset U/CSF Protein5 levels: 10, 20, 40, 80, 200 mg/dL0.9 % NaCl used for a 0 mg/dL level | Same |
| Quality control | Commercially available urine and CSFprotein controls | Same |
| Traceability | This method has been standardizedagainst the National Bureau ofStandards Reference Material SRM927a using the biuret method for thequantitation of protein | Same |
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510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued
| Feature | Predicate device:Roche/Hitachi Urinary/CSF ProteinK913615 | 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 | Meanmg/dL | SDmg/dL | CV% | Sample | Meanmg/dL | SDmg/dL | CV% | Meanmg/dL | SDmg/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 | Meanmg/dL | SDmg/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 | Meanmg/dL | SDmg/dL | CV% | Within-run (n = 20) | Between-run (n = 10) | ||||||
| Sample | Meanmg/dL | SDmg/dL | CV% | Meanmg/dL | SDmg/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 | Meanmg/dL | SDmg/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
:
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510(k) Summary - Roche/Hitachi Urinary/CSF Protein, Continued
| Feature | Predicate device:Roche/Hitachi Urinary/CSF ProteinK913615 | Modified device:Roche/Hitachi Urinary/CSF Protein,Additional RATE Application |
|---|---|---|
| Measuringrange | Endpoint Assay:2-200 mg/dL | Endpoint Assay:2-200 mg/dL |
| If results exceed the upper limit of themeasuring range, dilute the specimenwith isotonic saline and repeat the | Rate Assay:6-200 mg/dL | |
| assay. | Determine samples with U/CSFprotein concentrations > 200 mg/dL(2000 mg/L) via the rerun function.On instruments without rerunfunction, manually dilute sampleswith 0.9% NaCl. Multiply theresult by the appropriate dilutionfactor. | |
| Lowerdetection limit | 2 mg/dL | Endpoint Assay:2 mg/dL |
| Rate Assay6 mg/dL | ||
| Expectedvalues(literaturereference) | Urine Random: < 12 mg/dLUrine 24h: < 150 mg/dayCSF: 15-45 mg/dL | Urine 24h: < 150 mg/dayCSF: 15-45 mg/dL |
| Endogenousinterferences** | Hemolysis or RBC contaminationinterferes with the assay | Icterus: No significant interferenceup to an I index of 36 (approximateconjugated concentration: 36 |
| Reference to Young et aland 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
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510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued
| Feature | Predicate device:Roche/Hitachi Urinary/CSF ProteinK913615 | Modified device:Roche/Hitachi Urinary/CSF Protein,Additional RATE Application |
|---|---|---|
| Exogenousinterferences** | There is no significant interferencefrom the following substances:Ascorbic Acid, Creatinine, Glucose,Phosphorus, Urea, Magnesium,Sodium Citrate, Caffeine, CefazolinSodium, Chlorpromazine, Calcium L-Dopa, Gentamicin Sulfate, SodiumOxalate and Uric Acid | No significant interference from:Ascorbic Acid, Creatinine, Glucose,Phosphorus, Urea, Magnesium,Sodium Citrate, Caffeine, CefazolinSodium, Chlorpromazine, Calcium L-Dopa, Gentamicin Sulfate,Sodium Oxalate and Uric AcidTherapeutic concentrations of Ca-dobesilate, levodopa andphenazopyridine interfere with theassay.The administration of gelatin-basedplasma replacements canlead to increased urine proteinvalues.In very rare cases gammopathy, inparticular type IgM (Waldenström'smacroglobulinemia), may causeunreliable results. |
Substantial equivalency – Similarities (continued)
** Data on interferences applies to both the endpoint and the additional rate application
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510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued
Substantial equivalency – Similarities (continued)
| Feature | Predicate device:Roche/Hitachi Urinary/CSF ProteinK913615 | Modified device:Roche/Hitachi Urinary/CSF Protein,Additional RATE Application |
|---|---|---|
| Methodcomparison | A comparison of this method on theHitachi 717 analyzer using the DuPontACA method as the reference resultedin the following linear regressionstatistics:Urine samples:y= 1.051x +2.78r = 0.996n=34CSF samples:y = 0.992x - 0.957r = 0.982n=59 | A comparison of the U/CSFProtein determination with RocheDiagnostics U/CSF Protein reagentusing the rate application (y) withthe same reagent using the endpointapplication (x) gave the followingcorrelations (mg/dL):Urine samples:Passing/Babloky = 0.988x - 0.434r = 1.000Number of samples measured: 60The sample concentrations werebetween 1.7 and 3286.5 mg/dL.Statistics include all results (dilutedand undiluted).CSF samples:Passing/Babloky = 0.984x + 0.480r = 1.000Number of samples measured: 50The sample concentrations werebetween 5.8 and 110.2 mg/dL. |
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510(k) Summary – Roche/Hitachi Urinary/CSF Protein,
Continued
| ProposedLabeling | Proposed labeling sufficient to describe the device, its intended use, and thedirections for use are included. We believe the proposed version of the devicelabeling presented contains all of the technical information required per 21CFR 809.10. | |
|---|---|---|
| Validation andDesign Control | Development activities were conducted under appropriate design controlprocedures and the overall product specifications were met. The Declarationof Conformity with Design Controls and Results of Risk Analysis areprovided. | |
| Closing | The modification of the Roche/Hitachi Urinary/CSF Protein reagent describedabove does not affect the intended use or indications for use of the device asdescribed in the labeling, nor does it alter the fundamental scientifictechnology of the device. Therefore, we trust the information provided in thisSpecial 510(k) will support a decision of substantial equivalence of theRoche/Hitachi Urinary/CSF Protein with the Rate application to its predicate. | |
| If you have any questions or require further information, please do nothesitate to contact this office. | ||
| Kerwin Kaufman, MBA, MT(ASCP) | ||
| Regulatory Affairs PrincipalRoche Diagnostics• Phone: (317) 521-7637• FAX: (317) 521-2324• email: Kerwin.Kaufman@roche.com |
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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).
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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.
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
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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
§ 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.