(210 days)
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.
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.
The provided document describes the Tina-quant Albumin Gen. 2 Assay, an immunoturbidimetric test for quantitative determination of albumin in human urine. The submission primarily focuses on establishing substantial equivalence to a previously cleared device (Tina-quant Albumin Gen.2 - cobas c 501 urine assay, K101203).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, performance characteristics of the new device (Tina-quant Albumin Gen. 2 - cobas c 311 urine assay) are presented and compared against those of the predicate device (Tina-quant Albumin Gen. 2 - cobas c 501 urine assay) to demonstrate substantial equivalence. The implication is that the performance of the new device aligns sufficiently with the predicate.
Here's a table summarizing the reported device performance, with the understanding that these values are being compared for substantial equivalence and implicitly serve as acceptable performance benchmarks based on the predicate device.
| Feature | Implicit Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Albumin Gen. 2 - cobas c 311) |
|---|---|---|
| Measuring Range | 12-400 mg/L | 12-200 mg/L |
| Precision (Repeatability) | ||
| - Level 1 (e.g., 30.7 mg/L) | SD = 0.2, CV = 0.8% | Mean = 32.0, SD = 0.2, CV = 0.7% |
| - Level 2 (e.g., 108 mg/L) | SD = 1, CV = 0.7% | Mean = 101, SD = 1, CV = 1.2% |
| - Level 3 (e.g., 14.3 mg/L) | SD = 0.2, CV = 1.6% | Mean = 10.7, SD = 0.2, CV = 2.2% |
| - Level 4 (e.g., 252 mg/L) | SD = 4, CV = 1.6% | Mean = 132, SD = 2, CV = 1.9% |
| Precision (Intermediate Precision) | ||
| - Level 1 (e.g., 31.2 mg/L) | SD = 0.5, CV = 1.7% | Mean = 31.3, SD = 0.6, CV = 1.9% |
| - Level 2 (e.g., 105 mg/L) | SD = 1, CV = 1.2% | Mean = 97.9, SD = 0.7, CV = 0.7% |
| - Level 3 (e.g., 13.6 mg/L) | SD = 0.4, CV = 2.8% | Mean = 13.6, SD = 0.4, CV = 2.9% |
| - Level 4 (e.g., 60.6 mg/L) | SD = 1.4, CV = 2.3% | Mean = 63.7, SD = 0.7, CV = 1.1% |
| Analytical Sensitivity | ||
| - Limit of Blank (LoB) | 2 mg/L | 2 mg/L |
| - Limit of Detection (LoD) | 3 mg/L | 3 mg/L |
| - Limit of Quantitation (LoQ) | 12 mg/L | 12 mg/L |
| Analytical Specificity | No interference at therapeutic concentrations; no false result without flag up to 40000 mg/L Albumin | No interference at therapeutic concentrations; no false result without flag up to 40000 mg/L Albumin |
| Interferences | Recovery within ± 10% (for icterus, hemolysis, certain substances) | Recovery within ± 10% (for icterus, hemolysis, certain substances) |
| Method Comparison | Linear regression: y = 1.038x - 1.066 mg/L, r = 0.999 | Passing Bablock: y = 1.036x + 0.415 mg/L, $\tau$ = 0.972 |
Note: For many features (Assay Protocol, Sample Type, Calibrator, Calibration Frequency, Controls, Reagent Stability, Analytical Specificity, and Interferences), the predicate device's performance implicitly serves as the acceptance criterion, and the new device is stated to be "Same" or to have met the same criteria.
The measuring range of the new device (12-200 mg/L) is narrower than the predicate (12-400 mg/L), but this difference is not flagged as a concern for substantial equivalence in the document.
2. Sample Size Used for the Test Set and Data Provenance:
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Method Comparison:
- Sample Size: n = 69
- Data Provenance: Not explicitly stated (e.g., country of origin). The document states "human urine samples," but does not specify if they were collected retrospectively or prospectively.
-
Precision (Repeatability & Intermediate Precision): The sample sizes for these studies are not explicitly stated, nor is the data provenance. Usually, these involve multiple runs and replicates of control or spiked samples.
-
Analytical Sensitivity, Specificity, and Interferences: Sample sizes and data provenance are not provided for these studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The studies performed (method comparison, precision, analytical sensitivity, specificity, interferences) are laboratory-based and involve technical measurements rather than interpretations by medical experts for establishing ground truth in the traditional sense of diagnostic imaging or clinical decision-making.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided. The studies detailed are analytical performance studies of a laboratory assay, not studies requiring expert adjudication methods like 2+1 or 3+1 that are common in diagnostic imaging or clinical studies.
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 information is not applicable. The device is an in vitro diagnostic assay (a laboratory test) and does not involve human readers interpreting images or data that would be assisted by AI. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
This information is not applicable in the context of AI. The device itself is an automated immunoturbidimetric assay on an instrument (cobas c 311). Its performance, as described by precision, sensitivity, specificity, and method comparison, represents the "standalone" or "algorithm only" performance of the assay on the instrument without human interpretation of raw data. There is no AI component that would require a separate "human-in-the-loop" study.
7. The Type of Ground Truth Used:
- Method Comparison: The "ground truth" for the method comparison study is implicitly the measurement obtained from the predicate device (Tina-quant Albumin Gen. 2 - cobas c 501 assay, K101203). The study compares the new device's results against the predicate device's results.
- Precision: Ground truth is established by the known concentrations of control or spiked samples used in the precision studies.
- Analytical Sensitivity: Ground truth for LoB, LoD, and LoQ is determined through statistical analysis of blank and low-concentration samples.
- Analytical Specificity and Interferences: Ground truth is established by known concentrations of interfering substances added to samples, and observing the recovery of the albumin measurement.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable in the context of this device. The Tina-quant Albumin Gen. 2 Assay is a chemical/immunological assay, not a machine learning or AI-based device that requires a "training set." The assay relies on established chemical reactions and optical detection, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated in point 8.
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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 Diagnostics9115 Hague RoadIndianapolis, IN 46250Phone: (317) 521 - 3954Fax: (317) 521 - 2324Contact Person: Patrick StimartDate Prepared: October 4, 2011 |
| Device Name | Proprietary names: Tina-Quant Albumin Gen. 2Common names: Albumin Gen. 2 - cobas c 311 urine assayRegulation: 21 CFR 866.5040Classification names: Albumin Immunological Test SystemProduct 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. |
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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.
| Substantialequivalence -comparison | ||
|---|---|---|
| Feature | Tina-quant Albumin Gen. 2 - cobasc 311 urine Assay | Tina-quant Albumin Gen. 2 -cobas c 501 urine AssayPredicate device - K101203 |
| Intended Use | For cobas c 311: In vitro test for thequantitative determination of albuminin human urine. | In vitro test for the quantitativedetermination of albumin in humanurine, serum, plasma and CSF onRoche/Hitachi cobas c systems. |
| Assay Protocol | Immunoturbidimetric | Same |
| Sample Type | Urine | Same |
| LabeledInstrumentPlatform | Roche/Hitachi cobas c systems -cobas c 311 | Roche/Hitachi cobas c systems -cobas c 501 |
| Calibrator | C.f.a.s. PUC | Same |
| CalibrationFrequency | - after reagent lot change- as required following quality controlprocedures | Same |
| Controls | UrinePrecinorm PUC and Precipath PUCIn addition, other suitable controlmaterial can be used. | Same |
| ReagentStability | On-board in use: 12 weeks at 2-8° C | Same |
| MeasuringRange | 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% | |
| AnalyticalSensitivity | Limit of Blank (LoB) =2 mg/LLimit of Detection (LoD) =3 mg/LLimit of Quantitation (LoQ) =12 mg/L | Same |
| AnalyticalSpecificity | No interference was found attherapeutic concentrations usingcommon drug panels.High dose hook-effect: Using theprozone check, no false resultwithout a flag was observed up to analbumin concentration of 40000 mg/L | Same |
| Interferences | Criterion: Recovery within ± 10%Icterus: no significant interference up toa conjugated bilirubin concentration of 50mg/dL.Hemolysis: No significant interferenceup to a hemoglobin concentration of 400mg/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 ≤0.19mol/L, urea ≤0.8 mol/L, uric acid ≤5.95mmol/L and urobilinogen ≤378 umol/L. | Same |
| Expected | 2nd morning urine: | Same |
| Values | Adults:<20 mg albumin/g creatinine or <2.26 g albumin/mol creatinine | |
| Children (3-5 years):<20 mg/L albumin<37 mg albumin/g creatinine | ||
| 24 hour urine:<20 mg/L<30 mg/24 h | ||
| MethodComparisons | A comparison of the Roche Tina-quant Albumin Gen. 2 assay on the c 501analyzer (K101203) (x) with the Roche Tina-quant Albumin Gen. 2 assay onthe c 311 analyzer (y) for human urine samples gave the following correlation: | |
| Passing Bablock$y = 1.036x + 0.415$ mg/L$\tau = 0.972$ | Linear Regression$y = 1.038x - 1.066$ mg/L$r = 0.999$ | |
| n = 69Sample concentrations were between 13.0 and 189.6 mg/L |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - CSA" arranged in a circle around a stylized image of an eagle. The eagle is facing right and has its wings spread. The seal is black and white.
10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Patrick Stimart 9115 Hague Road Indianapolis, IN 46250-0416
MAY 1 4 2012
K113072 Re:
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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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
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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
§ 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.