(134 days)
No
The device description and performance studies focus on a standard immunoturbidimetric assay and do not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for the quantitative determination of albumin, which aids in diagnosis. It does not provide therapy.
Yes
The device is described as an "immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF". It explicitly states that "Measurement of albumin aids in the diagnosis of kidney and intestinal diseases." This indicates its role in disease diagnosis.
No
The device is an immunoturbidimetric assay, which is a laboratory test method involving reagents and a physical process to measure albumin levels. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "intended for the quantitative determination of albumin in serum, plasma, urine, and CSF". This indicates that the device is used to test samples taken from the human body (in vitro) to provide information about a person's health.
- Diagnosis: The intended use also states that the measurement of albumin "aids in the diagnosis of kidney and intestinal diseases." This directly links the test results to diagnostic purposes.
- Device Description: The description details a laboratory test method (immunoturbidimetric assay) performed on a laboratory instrument (Roche/Hitachi cobas c systems). This is characteristic of an in vitro diagnostic device.
- Sample Types: The assay is designed to analyze biological samples (serum, plasma, urine, and CSF), which are collected from the human body.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Tina-quant Albumin Gen. 2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
Product codes (comma separated list FDA assigned to the subject device)
DCF
Device Description
The Tina-quant Albumin Gen. 2 assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine, serum, plasma and CSF
Indicated Patient Age Range
Adults, Children (3-5 years), Newborns 0-4d, Children 4d-14yr, Children 14-18yr
Intended User / Care Setting
Not Found
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)
Precision (Urine Application):
cobas c501:
Repeatability (Within-run) (mg/L):
Mean = 30.7, SD = 0.2, CV = 0.8%
Mean = 108, SD = 1, CV = 0.7%
Mean = 14.3, SD = 0.2, CV = 1.6%
Mean = 252 mg/L, SD = 4, CV = 1.6%
Intermediate Precision (Total) (mg/L):
Mean = 31.2, SD = 0.5, CV = 1.7%
Mean = 105, SD = 1, CV = 1.2%
Mean = 13.6, SD = 0.4, CV = 2.8%
Mean = 60.6, SD = 1.4, CV = 2.3%
Analytical Sensitivity (Urine Application):
Limit of Blank (LoB) =2 mg/L
Limit of Detection (LoD) =3 mg/L
Limit of Quantitation (LoQ) =12 mg/L
Analytical Specificity (Urine Application):
No interference was found at common therapeutic concentrations using common drug panels.
Due to the antigen excess check reagent R3, no unflagged high-dose hook effect will occur up to an albumin concentration of 40000 mg/L.
Interferences (Urine Application):
Criterion: Recovery within ± 10%
Icterus: no significant interference up to an I index of 50 (approximate conjugated bilirubin concentration: 50 mg/dL)
Hemolysis: No significant interference up to an H index of 400 (approximate hemoglobin concentration: 400 mg/dL)
No interference by acetone
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.
0
ﺮ
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| Phone: (317) 521 - 3831 | |
| Fax: (317) 521 - 2324 | |
| Contact Person: Kathie J. Goodwin | |
| Date Prepared: April 23 rd , 2010 | |
| Device Name | Proprietary names: Tina-Quant Albumin Gen. 2 |
| Common names: Albumin Gen. 2 assay | |
| Regulation: 21 CFR 866.5040 | |
| Classification names: Albumin Immunological Test System | |
| Product codes: DCF | |
| Device Description | The Tina-quant Albumin Gen. 2 assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically. |
| Intended use | Immunoturbidimetric assay for the quantitative, in vitro determination of albumin in human urine, serum, plasma and CSF on Roche/Hitachi cobas c systems. |
| Indications for Use | The Tina-quant Albumin Gen. 2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. |
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Substantial The urine application of the Tina-quant Albumin Gen. 2 assay is substantially equivalence equivalent to the Hitachi Microalbumin urine assay. The Hitachi Microalbumin urine assay was cleared under K932950.
The Serum/plasma and CSF applications of the Tina-quant Albumin Gen. 2 assays are substantially equivalent to the Behring Nephelometric method cleared in K972929.
Substantial equivalence – comparison
| Feature | Tina-quant Albumin Gen. 2 Assay
Urine Application | Predicate Device: Hitachi
Microalbumin Urine Assay
(K932950) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro test for the quantitative
determination of albumin in human
urine, serum, plasma and CSF
(albumin CSF/serum ratio) on
Roche/Hitachi cobas c systems. | For the quantitative determination of
low levels of albumin in urine
(Microalbumin, MAU). |
| Assay Protocol | Immunoturbidimetric | Same |
| Sample Type | Urine | Same |
| Labeled
Instrument
Platform | Roche/Hitachi cobas c analyzer -
cobas c501 | Boehringer Mannheim/Hitachi 747
analyzer |
| Calibrator | C.f.a.s. PUC | Microalbumin calibrators (included in
kit) |
| Calibration
Frequency | Calibrate after reagent lot change
and as required following quality
control procedures | Perform full calibration every two
weeks. |
| Controls | Precinorm PUC and Precipath PUC
or
Precinorm Protein and Precipath
Protein | Precinorm Albumin and Precipath
Albumin |
| Reagent Stability | On-board in use:
12 weeks at 2-8 Deg. C | On-board in use:
4 weeks at 2-12 Deg. C |
| Measuring
Range | c501:
12-400 mg/L | 3 mg/L up to the value of the highest
calibrator |
| Precision | cobas c501:
Repeatability (Within-run) (mg/L):
Mean = 30.7, SD = 0.2, CV = 0.8%
Mean = 108, SD = 1, CV = 0.7%
Mean = 14.3, SD = 0.2, CV = 1.6%
Mean = 252 mg/L, SD = 4, CV =
1.6% | Within-run (mg/L):
Mean = 9.0, SD = 0.29, CV = 3.2%
Mean = 22.1, SD = 0.30, CV = 1.4%
Mean = 81.1, SD = 0.67, CV = 0.8% |
| | Intermediate Precision (Total)
(mg/L):
Mean = 31.2, SD = 0.5, CV = 1.7%
Mean = 105, SD = 1, CV = 1.2%
Mean = 13.6, SD = 0.4, CV = 2.8%
Mean = 60.6, SD = 1.4, CV = 2.3% | Total (mg/L):
Mean = 9.0, SD = 0.92, CV = 10.1%
Mean = 22.1, SD = 1.15, CV = 5.2%
Mean = 81.1, SD = 0.78. CV = 1.0% |
| Analytical
Sensitivity | Limit of Blank (LoB) =2 mg/L
Limit of Detection (LoD) =3 mg/L
Limit of Quantitation (LoQ) =12 mg/L | Lower Detection Limit = 3 mg/L |
| Analytical
Specificity | No interference was found at
common therapeutic concentrations
using common drug panels.
Due to the antigen excess check
reagent R3, no unflagged high-dose
hook effect will occur up to an
albumin concentration of 40000
mg/L. | No interference was observed from 18
common drugs. |
| | Note: calibrator values were lot
specific. In one representative lot,
values (mg/L) were:
Cal 3a: 0.0
Cal 3b: 10.5
Cal 3c: 62.6
Cal 3d: 154.0
Cal 3e: 347.0 | |
| Interferences | Criterion: Recovery within ± 10% | No significant interference observed from
calcium levels up to 100 mg/dL. |
| | Icterus: no significant interference up
to an I index of 50 (approximate
conjugated bilirubin concentration: 50
mg/dL) | Icterus: no significant interference from
bilirubin up to 25 mg/dL. |
| | Hemolysis: No significant interference
up to an H index of 400 (approximate
hemoglobin concentration: 400 mg/dL) | Hemolysis: Hemoglobin levels >300
mg/dL cause significant positive
interference. |
| | No interference by acetone ≤ 60
mmol/L, ammonia chloride ≤0.11
mol/L, calcium ≤40 mmol/L, Creatinine
≤0.18 mol/L, y-globulin ≤500 mg/L,
glucose ≤0.19 mol/L, urea ≤0.8 mol/L,
uric acid 4 years: 100 - 300 mg/L | Albumin in CSF: up to 350 mg/L |
| Method
Comparisons | A comparison of the Roche Tina-quant Albumin Gen. 2 assay on the cobas
c501 analyzer(x) with the nephelometric Albumin test gave the following
correlation: | |
| | Passing Bablock
$y = 1.000x - 8.75$ mg/L
$\tau = 0.936$ | Linear Regression
$y = 0.991x + 0.301$ mg/L
$r = 0.992$ |
| | n = 85 | |
| | Sample concentrations were between 115 and 2640 mg/L | |
.
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End of Document
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Image /page/9/Picture/0 description: The image shows a partial view of a document with the words "DEPARTMENT OF" visible. The text is in a bold, sans-serif font. To the left of the text is a logo or symbol consisting of three curved lines.
Roche Diagnostics c/o Kathie Goodwin 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Re: K101203
Trade Name: Tina-quant albumin gen 2 Regulation Number: 21 CFR §866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF Dated: September 9, 2010 Received: September 10, 2010
SEP 1 0 2010
Dear Ms. Goodwin:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
Indications for Use Form
K101203 510(k) Number (if known):
SEP 10 2010
Device Name: Tina-quant Albumin Gen. 2
Indications for Use:
The Tina-quant Albumin Gen. 2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101203
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