(134 days)
Not Found
No
The summary describes a quantitative in vitro diagnostic test using a reagent on an automated system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on method comparison and precision, which are standard for laboratory assays.
No
This device is an in vitro diagnostic test used for quantitative determination of total protein in urine and cerebrospinal fluid, which aids in diagnosis and treatment, but does not itself provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases". It further specifies that protein measurements are used "in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders" and "in diagnosis and treatment of disease conditions such as meningitis, brain tumors and infections of the central nervous systems." These statements clearly indicate its use in diagnosing medical conditions.
No
The device description explicitly states it is a "reagent" intended for use on specific hardware systems (COBAS INTEGRA systems and Roche/Hitachi cobas c systems), indicating it is a chemical component used in conjunction with hardware, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "In vitro test for the quantitative determination of the total protein in urine and cerebrospinal fluid". It also describes how the measurements are used in the diagnosis and treatment of various diseases.
- Device Description: The description refers to a "reagent" used for "quantitative determination of protein in urine and cerebrospinal fluid". Reagents used for testing biological samples outside the body are characteristic of IVDs.
- Performance Studies: The document details method comparison and precision studies performed on the device using urine and CSF samples. This type of testing is standard for evaluating the performance of IVD devices.
- Predicate Device: A predicate device (K913615; Roche Hitachi Urinary/CSF Protein) is listed, which is another IVD device. This further confirms the nature of the described device.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
JGQ, JIX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison studies were performed.
COBAS INTEGRA 800:
Urine: Sample size (n) = 54. Passing/Bablok y = 1.003x + 2.0 mg/L, tau = 0.951. Linear regression y = 1.007x + 4.2 mg/L, r = 0.999. 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. Sample concentrations were between 59 and 1996 mg/L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
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.
Measuring range:
Roche/Hitachi: 2-200 mg/dl (20-2000 mg/l)
COBAS INTEGRA: 40-2000 mg/L. Extended measuring range: 40-6000 mg/L with post dilution factor of 3 recommended.
Lower detection limit:
Roche/Hitachi: 20 mg/L
COBAS INTEGRA: 40 mg/L
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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. |
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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: 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)