(146 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay using a turbidimetric method on a COBAS Integra analyzer. There is no mention of AI, ML, image processing, or any data analysis techniques that would typically involve AI/ML. The performance studies focus on chemical interference and hook effect, not on algorithmic performance.
No.
This device is an in vitro diagnostic test for measuring total protein concentration in urine and cerebral spinal fluid, which is used in the diagnosis and treatment of disease conditions. It does not directly treat or prevent a disease or condition.
Yes
The device quantitatively measures total protein concentration in urine and cerebral spinal fluid, which is stated to be used in the diagnosis and treatment of various disease conditions like renal or heart diseases, thyroid disorders, meningitis, brain tumors, and central nervous system infections.
No
The device is an in vitro diagnostic assay that utilizes reagents and is intended for use with a specific analyzer (COBAS Integra 400 plus). This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "In vitro test for the quantitative determination of the total protein concentration in urine and cerebral spinal fluid." This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body.
- Device Description: The description details reagents and how the measurement is accomplished using a turbidimetric method, which is a common technique used in laboratory diagnostic testing.
- Anatomical Site: The samples tested are urine and cerebral spinal fluid, both of which are human biological specimens.
- Performance Studies: The document describes performance studies conducted to evaluate the device's performance with human samples (pooled human urine).
All of these factors indicate that the device is designed to be used outside of the human body to examine specimens for diagnostic purposes, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
In vitro test for the quantitative determination of the total protein concentration in urine and cerebral spinal fluid.
Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders.
CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous systems.
Product codes (comma separated list FDA assigned to the subject device)
JIO
Device Description
The Total Protein Urine/CSF assay provides quantitative measurement of total protein that is present in human urine and cerebral spinal fluid (CSF). Measurement is accomplished using a turbidimetric method. Reagents for the COBAS Integra 400 plus analyzer are packaged in a cobas c pack with two bottles labeled with their instrument positioning, Reagent R1 in position B and Reagent SR in position C. R1 contains Sodium Hydroxide: 677 mmol/L; EDTA-Na: 74 mmol/L SR contains Benzethonium chloride: 32 mmol/L
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the risk analysis, the modifications to the Total Protein Urine/CSF Gen.3 did not introduce any new risks to the performance of the assay. To address the modifications, performance data from verification and validation testing demonstrated that all of the acceptance criteria were met.
Testing of interference by radiopaque media: Testing is performed in pooled human urine samples at two different total protein levels on the Integra 400 plus analyzer. Each level is spiked with varying levels of the radiopaque media Hexabrix containing organically bound iodine (10 dilution steps per level) which were tested in triplicate and the median value was used to calculate % deviation from expected concentration. Acceptance criterion: Deviation
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ROCHE DIAGNOSTICS OPERATIONS (RDO) PATRICK STIMART REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250
December 9, 2014
Re: K141925
Trade/Device Name: TPUC3 Total Protein Urine/CSF Gen.3 Regulation Number: 21 CFR 862.1645 Regulation Name: Urinary protein or albumin (nonquantitative) test system Regulatory Class: I exempt, meets limitations of exemptions per 862.9 (c)(1)(4) Product Code: JIO Dated: November 7, 2014 Received: November 10, 2014
Dear Mr. Patrick Stimart:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141925
Device Name Total Protein Urine/CSF Gen.3
Indications for Use (Describe)
In vitro test for the quantitative determination of the total protein concentration in urine and cerebral spinal fluid.
Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders.
CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Introduction | The following information provides sufficient detail to understand the basis for a
determination of substantial equivalence according to the requirements of 21 CFR
807.92.
Note: There were no prior submissions for this device for which FDA provided
feedback related to the data or information needed to support substantial
equivalence. | | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|--|--|
| Applicant | This Special 510(k) premarket notification was prepared by Patrick Stimart from
Roche Professional Diagnostics Regulatory Affairs and submitted on July 15, 2014. | | | |
| | Roche Diagnostics Operations
c/o Patrick Stimart, Regulatory Affairs
PO Box 50416
Indianapolis IN 46250-0416 | | | |
| | Phone: 317-521-3954
Fax: 317-521-2324
e-mail: patrick.stimart(@roche.com | | | |
| Candidate
device | Proprietary name: TPUC3 Total Protein Urine/CSF Gen.3
Common name: Total Protein Urine/CSF | | | |
| Measurand | Total Protein | | | |
| Predicate
device | The candidate device is a modification of the predicate device. The device name,
TPUC3 Total Protein Urine/CSF Gen.3, is unchanged from how it was cleared in
510(k) K071239. | | | |
| Regulatory | Table 1: Regulatory Classification of Candidate Device | | | |
| classification of | Device Classification Name | Urinary protein or albumin test system | | |
| device | Produce Code | JIQ | | |
| | Device Class | ]* | | |
| | Regulation | 862.1645 | | |
| | Panel | Clinical Chemistry | | |
| | | | | |
4
Continued
| Regulatory
classification of
device
(Continued) | * Although the regulation for this assay lists it as Class I, exempt from 510(k)
requirements, a 510(k) submission is required because the Total Protein Urine/CSF
Gen.3 assay meets the limitations for exemption found in 21 CFR 862.9 (c) 1 and 4. |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | The Total Protein Urine/CSF assay provides quantitative measurement of total
protein that is present in human urine and cerebral spinal fluid (CSF). Measurement
is accomplished using a turbidimetric method.
Reagents for the COBAS Integra 400 plus analyzer are packaged in a cobas c pack
with two bottles labeled with their instrument positioning, Reagent R1 in position B
and Reagent SR in position C.
R1 contains Sodium Hydroxide: 677 mmol/L; EDTA-Na: 74 mmol/L
SR contains Benzethonium chloride: 32 mmol/L |
| Intended
use/indications
for use | In vitro test for the quantitative determination of the total protein concentration in
urine and cerebral spinal fluid.
Protein measurements in urine are used in the diagnosis and treatment of disease
conditions such as renal or heart diseases, or thyroid disorders.
CSF protein measurements are used in the diagnosis and treatment of conditions
such as meningitis, brain tumors and infections of the central nervous systems.
Note: The intended use of the modified device, as described in its labeling, has not
changed as a result of the modification. |
| Special
conditions for
use | For prescription use only |
| Special
instruments
required | For use on the Roche COBAS Integra 400 plus analyzer |
| | Continued on next page |
5
Continued
| Device
modification | The candidate device, Total Protein Urine/CSF Gen.3, has been modified from the
predicate device with the addition of the following information to the Limitations-
interferences section of the labeling:
Patient samples containing greater than 6.4 g/L of organically bound iodine
from Radiopaque media (e.g. Hexabrix) may have falsely elevated results. High levels of homogentisic acid can be found in the urine of patients with
the rare genetic disorder Alkaptonuria10. Homogentisic acid in urine
samples at concentration greater than 1.2 mmol/L can cause falsely elevated
results. There is no high dose hook effect at protein concentrations up to 100 g/L. |
| ------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
6
Continued
| Feature | Predicate Device | Candidate Device | |
|---|---|---|---|
| Total Protein Urine/CSF | |||
| Gen.3 | Total Protein Urine/CSF | ||
| Gen.3 | |||
| In vitro test for the | |||
| quantitative determination of | |||
| the total protein concentration | |||
| in urine and cerebrospinal | |||
| fluid on COBAS INTEGRA | |||
| systems. | same | ||
| Intended | |||
| use/indications for | |||
| use | 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 the diagnosis and | |||
| treatment of conditions such | |||
| as meningitis, brain tumors | |||
| and infections of the central | |||
| nervous systems. | same | ||
| Test principle | Turbidimetric method | same | |
| Sample volume | 10 µL | same | |
| Sample types | Urine and cerebral spinal | ||
| fluid (CSF) | same | ||
| Reagents | R1: Sodium hydroxide 677 | ||
| mmol/L; EDTA-Na 74 | |||
| mmol/L | |||
| SR: Benzethonium chloride | |||
| 32 mmol/L | same | ||
| Similarities, | |||
| continued | Feature | Predicate Device | Candidate Device |
| Table 4: Similarities between Predicate and Candidate Devices | |||
| Total Protein Urine/CSF | |||
| Gen.3 | Total Protein Urine/CSF | ||
| Gen.3 | |||
| Calibration | |||
| interval | COBAS INTEGRA 400 plus | ||
| system: | |||
| • each cobas c pack | |||
| • every 43 days | |||
| • as required following | |||
| quality control | |||
| procedures | same | ||
| Traceability | Traceability: This method has | ||
| been standardized against the | |||
| National Bureau of Standards | |||
| Reference Material SRM-927 | |||
| using the biuret method for | |||
| the quantitation of protein. | same | ||
| Reagent stability | Shelf life at 15-25 °C | ||
| See expiration date on cobas | |||
| c pack label | |||
| COBAS INTEGRA 400 plus | |||
| system | |||
| On-board in use at 10-15 °C | |||
| 12 weeks | same | ||
| Measuring range | 40-2000 mg/L (4-200mg/dL) | same | |
| Lower detection | |||
| limit | 40 mg/L (4 mg/dL) | same | |
| Expected values | Urine: 24h: |