(210 days)
No
The description focuses on a standard immunoturbidimetric assay and does not mention any AI or ML components.
No.
This device is an in-vitro diagnostic test used for the quantitative determination of albumin in human urine, which aids in the diagnosis of kidney and intestinal diseases. It does not provide any treatment or therapy.
Yes
The intended use states that "Measurement of albumin aids in the diagnosis of kidney and intestinal diseases." This indicates its role in identifying or confirming a disease or medical condition.
No
The device description clearly indicates it is an immunoturbidimetric assay that uses antibodies and measures agglutination turbidimetrically, which are chemical and physical processes, not solely software. It is intended for use on a specific hardware system (Roche/Hitachi cobas c systems).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of albumin in human urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro).
- Purpose: The measurement of albumin "aids in the diagnosis of kidney and intestinal diseases." This clearly indicates a diagnostic purpose.
- Device Description: The description details an "immunoturbidimetric test" performed on a "Roche/Hitachi cobas c systems," which are laboratory analyzers used for in vitro testing.
These points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Tina-quant Albumin Gen. 2 - cobas c 311 urine assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in urine on the Roche/Hitachi cobas c 311analyzers. 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 - cobas c 311 urine 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
Not Found
Indicated Patient Age Range
Not Found
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)
Method Comparisons: A comparison of the Roche Tina-quant Albumin Gen. 2 assay on the c 501 analyzer (K101203) (x) with the Roche Tina-quant Albumin Gen. 2 assay on the c 311 analyzer (y) for human urine samples gave the following correlation: Passing Bablock y = 1.036x + 0.415 mg/L, tau = 0.972, n = 69. Sample concentrations were between 13.0 and 189.6 mg/L. Linear Regression y = 1.038x - 1.066 mg/L, r = 0.999.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limit of Blank (LoB) =2 mg/L, Limit of Detection (LoD) =3 mg/L, Limit of Quantitation (LoQ) =12 mg/L.
Precision:
Repeatability (Within-run) (mg/L): Mean = 32.0, SD = 0.2, CV = 0.7%; Mean = 101, SD = 1, CV = 1.2%; Mean = 10.7, SD = 0.2, CV = 2.2%; Mean = 132, SD = 2, CV = 1.9%.
Intermediate Precision (Total) (mg/L): Mean = 31.3, SD = 0.6, CV = 1.9%; Mean = 97.9, SD = 0.7, CV = 0.7%; Mean = 13.6, SD = 0.4, CV = 2.9%; Mean = 63.7, SD = 0.7, CV = 1.1%.
Analytical Specificity: No interference was found at therapeutic concentrations using common drug panels. High dose hook-effect: Using the prozone check, no false result without a flag was observed up to an albumin concentration of 40000 mg/L.
Interferences: Criterion: Recovery within ± 10%. Icterus: no significant interference up to a conjugated bilirubin concentration of 50 mg/dL. Hemolysis: No significant interference up to a hemoglobin concentration of 400 mg/dL. 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 ≤5.95 mmol/L and urobilinogen ≤378 umol/L.
Expected Values:
2nd morning urine: Adults:
§ 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
K11.3072
:
Tina-quant Albumin Gen. 2 Assay
510(k) Summary
MAY 1 4 2012
:
| 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 - 3954 | |
| Fax: (317) 521 - 2324 | |
| Contact Person: Patrick Stimart | |
| Date Prepared: October 4, 2011 | |
| Device Name | Proprietary names: Tina-Quant Albumin Gen. 2 |
| Common names: Albumin Gen. 2 - cobas c 311 urine assay | |
| Regulation: 21 CFR 866.5040 | |
| Classification names: Albumin Immunological Test System | |
| Product codes: DCF | |
| Device Description | The Tina-quant Albumin Gen. 2 - cobas c 311 urine 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 on the Roche/Hitachi cobas c 311 analyzers. |
| Indications for Use | The Tina-quant Albumin Gen. 2- cobas c 311 urine assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in urine on the Roche/Hitachi cobas c 311analyzers. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. |
1
Tina-quant Albumin Gen. 2 Assay
Substantial equivalence
The Tina-quant Albumin Gen. 2 - cobas c 311 urine assay is substantially equivalent to the Tina-quant Albumin Gen.2 - cobas c 501 urine assay. The cobas c 501 Tina-quant Albumin Gen. 2 assay was cleared under K101203.
| Substantial
equivalence -
| comparison | ||
|---|---|---|
| Feature | Tina-quant Albumin Gen. 2 - cobas | |
| c 311 urine Assay | Tina-quant Albumin Gen. 2 - | |
| cobas c 501 urine Assay | ||
| Predicate device - K101203 | ||
| Intended Use | For cobas c 311: In vitro test for the | |
| quantitative determination of albumin | ||
| in human urine. | In vitro test for the quantitative | |
| determination of albumin in human | ||
| urine, serum, plasma and CSF on | ||
| Roche/Hitachi cobas c systems. | ||
| Assay Protocol | Immunoturbidimetric | Same |
| Sample Type | Urine | Same |
| Labeled | ||
| Instrument | ||
| Platform | Roche/Hitachi cobas c systems - | |
| cobas c 311 | Roche/Hitachi cobas c systems - | |
| cobas c 501 | ||
| Calibrator | C.f.a.s. PUC | Same |
| Calibration | ||
| Frequency | - after reagent lot change |
- as required following quality control
procedures | Same |
| Controls | Urine
Precinorm PUC and Precipath PUC
In addition, other suitable control
material can be used. | Same |
| Reagent
Stability | On-board in use: 12 weeks at 2-8° C | Same |
| Measuring
Range | 12-200 mg/L | 12-400 mg/L |
| Precision | Repeatability (Within-run) (mg/L):
Mean = 32.0, SD = 0.2, CV = 0.7%
Mean = 101, SD = 1, CV = 1.2%
Mean = 10.7, SD = 0.2, CV = 2.2%
Mean = 132, SD = 2, CV = 1.9% | 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, SD = 4, CV = 1.6% |
| | Intermediate Precision (Total) (mg/L):
Mean = 31.3, SD = 0.6, CV = 1.9%
Mean = 97.9, SD = 0.7, CV = 0.7%
Mean = 13.6, SD = 0.4, CV = 2.9%
Mean = 63.7, SD = 0.7, CV = 1.1% | 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 | Limit of Blank (LoB) =2 mg/L
Limit of Detection (LoD) =3 mg/L
Limit of Quantitation (LoQ) =12 mg/L | Same |
| Analytical
Specificity | No interference was found at
therapeutic concentrations using
common drug panels.
High dose hook-effect: Using the
prozone check, no false result
without a flag was observed up to an
albumin concentration of 40000 mg/L | Same |
| Interferences | Criterion: Recovery within ± 10%
Icterus: no significant interference up to
a conjugated bilirubin concentration of 50
mg/dL.
Hemolysis: No significant interference
up to a hemoglobin concentration of 400
mg/dL.
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 ≤5.95
mmol/L and urobilinogen ≤378 umol/L. | Same |
| Expected | 2nd morning urine: | Same |
| Values | Adults:
Trade Name: Tina-quant Albumin Gen.2 Regulation Number: 21 CFR 8866,5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Codes: DCF Dated: March 29, 2012 Received: April 2, 2012
Dear Mr. 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.
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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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportalProblem/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours.
N
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K113072
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 human urine on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
Prescription Use X (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 (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113072