Who is the manufacturer of TINA-QUANT ALBUMIN GEN 2?

Roche Diagnostics filed the 510(k) submission for TINA-QUANT ALBUMIN GEN 2 (K101203).

What is the FDA product code for TINA-QUANT ALBUMIN GEN 2?

DCF. It is classified under 21 CFR 866.5040 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for TINA-QUANT ALBUMIN GEN 2?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TINA-QUANT ALBUMIN GEN 2?

Hitachi Tina Quant microalbumin urine assay (k932950); Behring N Antiserum to Human Albumin Nephelometric method (k972929).

Who can help prepare an FDA 510(k) submission like TINA-QUANT ALBUMIN GEN 2?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TINA-QUANT ALBUMIN GEN 2

K101203 · Roche Diagnostics · DCF · Sep 10, 2010 · Immunology

Device Facts

Record ID	K101203
Device Name	TINA-QUANT ALBUMIN GEN 2
Applicant	Roche Diagnostics
Product Code	DCF · Immunology
Decision Date	Sep 10, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5040
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Tina-quant Albumin Gen. 2 is an in vitro diagnostic assay for quantitative albumin measurement in human urine, serum, plasma, and CSF. Used on Roche/Hitachi cobas c systems (e.g., c501), the device employs immunoturbidimetric technology. Anti-albumin antibodies react with sample antigen to form antigen/antibody complexes; agglutination is measured turbidimetrically. The system provides quantitative results to clinicians to aid in diagnosing kidney and intestinal diseases. The assay includes automated prozone/antigen excess checks to prevent false results at high albumin concentrations. Performance is validated through precision, sensitivity, and interference studies compared to predicate methods.

Clinical Evidence

Bench testing only. Performance validated via precision (repeatability and intermediate precision), linearity, and analytical specificity studies. Method comparison performed against predicate devices using 125 urine, 77 serum, and 85 CSF samples, showing high correlation (Pearson's r 0.992–0.999). Interference testing confirmed no significant impact from common drugs, lipemia, icterus, or hemolysis within specified limits.

Technological Characteristics

Immunoturbidimetric assay; utilizes anti-albumin antibodies. Form factor: liquid reagent kit for automated clinical chemistry analyzers (Roche/Hitachi cobas c systems). Connectivity: integrated with cobas c501 analyzer. Software: embedded firmware for instrument control and data processing. Measuring ranges: 12-400 mg/L (urine), 3-101 g/L (serum/plasma), 95-3000 mg/L (CSF).

Indications for Use

Indicated for quantitative determination of albumin in serum, plasma, urine, and CSF to aid in the diagnosis of kidney and intestinal diseases. Applicable to adults, children, and newborns.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Hitachi Tina Quant microalbumin urine assay (k932950)
Behring N Antiserum to Human Albumin Nephelometric method (k972929)

Reference Devices

Hitachi 917 analyzer (K953239)

Related Devices

K113072 — TINA-QUANT ALBUMIN GEN.2 · Roche Diagnostics Operations · May 14, 2012

Submission Summary (Full Text)

{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. | {1}------------------------------------------------ #### 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 <5.95 mmol/L and urobilinogen ≤378 umol/L. | Lipemia (Intralipid): No significant interference up to an L index of 200. There is poor correlation between the L index (corresponds to turbidity) and triglyceride concentration. | | Expected Values | 2nd morning urine: 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 | 2nd morning urine: Adults: same Children (3-5 years): same | | | 24 hour urine: <20 mg/L <30 mg/24 h | 24 hour urine: Microalbuminuria: 30-300 mg albumin/24 hr | | Method Comparisons | A comparison of the Roche Tina-quant Albumin Gen. 2 assay on the c501 analyzer(x) with the Hitachi Microalbumin assay on the Hitachi 917 analyzer (K953239) (y) gave the following correlation: | | | | Passing Bablock y = 1.023x + 3.64 mg/L $\tau$ = 0.984 | Linear Regression y = 1.028x - 4.13 mg/L r = 0.999 | | | n = 125 Sample concentrations were between 12.3 and 386 mg/L | | {2}------------------------------------------------ Page 3 of 9 . . : {3}------------------------------------------------ {4}------------------------------------------------ | Substantial equivalence - comparison Feature | Tina-quant Albumin Gen. 2 Assay Serum/Plasma Application | Predicate Device: Behring N Antiserum to Human Albumin Assay (K972929) | | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | 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. | | | Assay Protocol | Immunoturbidimetric | Same | | | Sample Type | Serum Plasma: Li-heparin and K2-EDTA | Serum | | | Labeled Instrument Platform | Roche/Hitachi cobas c analyzer – cobas c501 | BN Systems | | | Calibrator | C.f.a.s. PUC | N Protein Standard SL (human) | | | Calibration frequency | Full calibration is recommended after reagent lot change and as required following quality control procedures. | Same | | | Controls | Precinorm PUC and Precipath PUC or Precinorm Protein and Precipath Protein | N/T Protein Controls SL/L, M and H or N/T Protein Control LC | | | Measuring Range | c501: 3 – 101 g/L | Reference curves are generated by multi-point calibration. Serial dilutions on N Protein Standard SL are automatically prepared by the instrument using N Diluent. | | | | | | | | Precision | cobas c501: Repeatability (Within-run) (mg/L): Mean = 39.9, SD = 0.5, CV = 1.2% Mean = 66.6, SD = 1.4, CV = 1.2% Mean = 27.6, SD = 0.4, CV = 1.3% Mean = 62.5 mg/L, SD = 0.9, CV = 1.5% Intermediate Precision (Total) (mg/L): Mean = 42.3, SD = 0.9, CV = 2.0% Mean = 70.5, SD = 1.6, CV = 2.2% Mean = 7.78, SD = 0.74, CV = 9.5% Mean = 36.2, SD = 0.7, CV = 2.1% | Intra-assay (g/L): Mean: 46.5; CV: 4.3% Inter-assay (g/L) Mean: 44.7; CV: 4.4% | | | Analytical Sensitivity | Limit of Blank (LoB) = 1 g/dL Limit of Detection (LoD) = 2 g/dL Limit of Quantitation (LoQ) = 3 g/dL | Established by the lower limit of the reference curve and depends therefore upon the concentrations of the proteins in the N Protein Standard SL. | | | Analytical Specificity | No interference was found at common therapeutic concentrations using common drug panels. | No interference from commonly used drugs is known. | | | Interferences | Criterion: Recovery within ± 10% Icterus: no significant interference up to an I index of 60 (approximate conjugated bilirubin concentration: 60 mg/dL) Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL) Lipemia: No significant interference up to an L index of 1500 (approximate Intralipid concentration: 1500 mg/dL). There is poor correlation between the Intralipid concentration (corresponds to turbidity) and triglycerides concentration. Rheumatoid factors ≤ 1200 IU/mL do not interfere. | Turbidity and particles in the sample may interfere with the determination. Therefore, samples containing particles must be centrifuged prior to testing. Bovine serum albumin in the sample (e.g. control sample) may disturb the determination. | | | Expected Values | Reference Range Study: Adults: 3.56-4.61 g/dL | Adults: 35.0 - 52.0 g/L | | | | Consensus Values: | | | | | Adults: 3.5 - 5.2 g/dL | | | | | Reference Intervals according to Tietz: | | | | | Newborns 0-4d: 2.8 - 4.4 g/dL | | | | | Children 4d-14yr: 3.8 - 5.4 g/dL | | | | | Children 14-18yr: 3.2-4.5 g/dL | | | | A comparison of the Roche Tina-quant Albumin Gen. 2 assay on the cobas | | | | | Method | c501 analyzer(x) with the nephelometric Albumin test gave the following | | | | Comparison | correlation: | | | | | | | | | | Passing Bablock | Linear Regression | | | | y = -0.1320 + 0.9600x | y = -0.0095 + 0.9572x | | | | $\tau$ = 0.919 | r = 0.993 | | | | n = 77 | | | | | Sample concentrations were between 5.70 and 100 g/L | | | , ・ {5}------------------------------------------------ {6}------------------------------------------------ : ### Substantial equivalence – comparison ، | Feature | Tina-quant Albumin Gen. 2 Assay CSF Application | Predicate Device: Behring N Antiserum to Human Albumin Assay (K972929) | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | In vitro diagnostic reagent for the quantitative determination of albumin, prealbumin (transthyretin) and retinol-binding protein (RbP) in human serum as well as of albumin in human urine and cerebrospinal fluid (CSF) using the BN Systems | | Assay Protocol | Immunoturbidimetric | Same | | Sample Type | CSF | Same | | Labeled Instrument Platform | Roche/Hitachi analyzer - cobas c501 | BN Systems | : {7}------------------------------------------------ | Calibrator | C.f.a.s. PAC | N Protein Standard SL (human) | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Controls | Commercially available control | N/T Protein Controls SL/L, M and H or N/T Protein Control LC | | Measuring Range | c501: 95 - 3000 mg/L | Reference curves are generated by multi-point calibration. Serial dilutions on N Protein Standard SL are automatically prepared by the instrument using N Diluent. | | Precision | Repeatability (Within-run) (mg/L): Mean = 99.2, SD = 1.4, CV = 1.4% Mean = 174, SD = 3, CV = 1.7% Mean = 383, SD = 4, CV = 1.0% Mean = 454 mg/L, SD = 4, CV = 0.8% Intermediate Precision (Total) (mg/L): Mean = 91.0, SD=2.9, CV = 3.2% Mean = 389, SD = 7, CV = 1.7% Mean = 166, SD = 4, CV = 2.3% Mean = 366, SD = 5, CV = 1.3% | Not specified for CSF | | Analytical Sensitivity | Limit of Blank (LoB) = 20 mg/L Limit of Detection (LoD) = 36 mg/L Limit of Quantitation (LoQ) = 95 mg/L | Established by the lower limit of the reference curve and depends therefore upon the concentrations of the proteins in the N Protein Standard SL. | | Analytical Specificity | No interference was found at common therapeutic concentrations using common drug panels. | No interference from commonly used drugs is known. | {8}------------------------------------------------ | Interferences | Criterion: Recovery within ± 10% | Not specified for CSF. | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | | Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL) | | | | Icterus: No significant interference up to an I index 60 (approximate conjugated and unconjugated bilirubin concentration: 600 mg/L) | | | | High dose hook-effect: Using the prozone check, no false result without a flag was observed up to an albumin concentration of 30000 mg/L. | | | Expected Values | Albumin in CSF: 3 months to 4 year: < 450 mg/L > 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 | | . . End of Document · . . {9}------------------------------------------------ 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). {10}------------------------------------------------ Page 2 - 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): K101203 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 Page 1 of 1

TINA-QUANT ALBUMIN GEN 2

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

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TINA-QUANT ALBUMIN GEN 2

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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