(134 days)
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.
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.
The provided document describes the Tina-quant Albumin Gen. 2 assay, an immunoturbidimetric test for quantitative determination of albumin in human urine, serum, plasma and CSF on Roche/Hitachi cobas c systems.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents separate substantial equivalence comparisons for the urine, serum/plasma, and CSF applications of the Tina-quant Albumin Gen. 2 assay against predicate devices. The "acceptance criteria" are implied by the measured performance parameters, as they are being compared to the predicate device and found to be substantially equivalent.
Table 1: Urine Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Hitachi Microalbumin Urine Assay - K932950) | Reported Device Performance (Tina-quant Albumin Gen. 2 - Urine Application) |
|---|---|---|
| Precision | ||
| Within-run (mg/L) | Mean = 9.0, SD = 0.29, CV = 3.2% | Mean = 30.7, SD = 0.2, CV = 0.8% |
| Mean = 22.1, SD = 0.30, CV = 1.4% | Mean = 108, SD = 1, CV = 0.7% | |
| Mean = 81.1, SD = 0.67, CV = 0.8% | Mean = 14.3, SD = 0.2, CV = 1.6% | |
| Mean = 252 mg/L, SD = 4, CV = 1.6% | ||
| Total (mg/L) | Mean = 9.0, SD = 0.92, CV = 10.1% | Mean = 31.2, SD = 0.5, CV = 1.7% |
| Mean = 22.1, SD = 1.15, CV = 5.2% | Mean = 105, SD = 1, CV = 1.2% | |
| Mean = 81.1, SD = 0.78, CV = 1.0% | Mean = 13.6, SD = 0.4, CV = 2.8% | |
| Mean = 60.6, SD = 1.4, CV = 2.3% | ||
| Analytical Sensitivity | Lower Detection Limit = 3 mg/L | LoB = 2 mg/L, LoD = 3 mg/L, LoQ = 12 mg/L |
| Analytical Specificity | No interference from 18 common drugs | No interference at common therapeutic concentrations |
| No unflagged high-dose hook effect up to 40000 mg/L | ||
| Interferences | Criterion: Recovery within ± 10% | |
| Icterus | No significant interference up to 25 mg/dL | No significant interference up to I index of 50 (approx. 50 mg/dL conjugated bilirubin) |
| Hemolysis | Hemoglobin levels >300 mg/dL cause significant positive interference | No significant interference up to H index of 400 (approx. 400 mg/dL hemoglobin) |
| Lipemia | No significant interference up to an L index of 200 | No interference by acetone, ammonia chloride, calcium, creatinine, y-globulin, glucose, urea, uric acid, urobilinogen (specific concentrations given) |
| Method Comparison | Linear Regression: y = 1.028x - 4.13 mg/L, r = 0.999 | Passing Bablock: y = 1.023x + 3.64 mg/L, $\tau$ = 0.984 |
| (Predicate on Hitachi 917 analyzer) | (Tina-quant on c501 analyzer vs. Hitachi Microalbumin on Hitachi 917) |
Table 2: Serum/Plasma Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Behring N Antiserum to Human Albumin Assay - K972929) | Reported Device Performance (Tina-quant Albumin Gen. 2 - Serum/Plasma Application) |
|---|---|---|
| Precision | ||
| Intra-assay (g/L) | Mean: 46.5; CV: 4.3% | |
| Inter-assay (g/L) | Mean: 44.7; CV: 4.4% | |
| Repeatability (Within-run) (mg/L) | Not directly comparable, but predicate shows ~4% CV | 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) | Not directly comparable, but predicate shows ~4% CV | 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% | ||
| Analytical Sensitivity | Established by lower limit of reference curve, depends on protein concentrations | LoB = 1 g/dL, LoD = 2 g/dL, LoQ = 3 g/dL |
| Analytical Specificity | No interference from commonly used drugs is known. | No interference at common therapeutic concentrations |
| Interferences | Turbidity and particles may interfere. Bovine serum albumin may disturb. | Criterion: Recovery within ± 10% |
| Icterus | Not specified in detail, but general interference noted. | No significant interference up to I index of 60 (approx. 60 mg/dL conjugated bilirubin) |
| Hemolysis | Not specified in detail, but general interference noted. | No significant interference up to H index of 1000 (approx. 1000 mg/dL hemoglobin) |
| Lipemia | Not specified in detail, but general interference noted. | No significant interference up to L index of 1500 (approx. 1500 mg/dL intralipid) |
| Rheumatoid factors | Not specified. | ≤ 1200 IU/mL do not interfere. |
| Method Comparison | Predicate calibrates by serial dilutions | Passing Bablock: y = -0.1320 + 0.9600x, $\tau$ = 0.919 |
| Linear Regression (provided): y = -0.0095 + 0.9572x, r = 0.993 | ||
| (Tina-quant on c501 analyzer vs. nephelometric Albumin test) | (Tina-quant on c501 analyzer vs. nephelometric Albumin test) |
Table 3: CSF Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Behring N Antiserum to Human Albumin Assay - K972929) | Reported Device Performance (Tina-quant Albumin Gen. 2 - CSF Application) |
|---|---|---|
| Precision | Not specified for CSF in predicate. | |
| 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% | ||
| Analytical Sensitivity | Established by lower limit of reference curve, depends on protein concentrations | LoB = 20 mg/L, LoD = 36 mg/L, LoQ = 95 mg/L |
| Analytical Specificity | No interference from commonly used drugs is known. | No interference at common therapeutic concentrations |
| Interferences | Not specified for CSF. | Criterion: Recovery within ± 10% |
| Hemolysis | No significant interference up to H index of 1000 (approx. 1000 mg/dL hemoglobin) | |
| Icterus | No significant interference up to I index 60 (approx. 600 mg/L conjugated and unconjugated bilirubin) | |
| High dose hook-effect | No false result without a flag up to 30000 mg/L albumin concentration | |
| Method Comparison | Predicate calibrates by serial dilutions. | Passing Bablock: y = 1.000x - 8.75 mg/L, $\tau$ = 0.936 |
| Linear Regression (provided): y = 0.991x + 0.301 mg/L, r = 0.992 | ||
| (Tina-quant on c501 analyzer vs. nephelometric Albumin test) | (Tina-quant on c501 analyzer vs. nephelometric Albumin test) |
2. Sample Size Used for the Test Set and Data Provenance
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Urine Application Method Comparison:
- Sample Size: n = 125
- Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). The comparison is between the Tina-quant Albumin Gen. 2 assay on the c501 analyzer and the Hitachi Microalbumin assay on the Hitachi 917 analyzer (K953239). The sample concentrations were between 12.3 and 386 mg/L.
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Serum/Plasma Application Method Comparison:
- Sample Size: n = 77
- Provenance: Not explicitly stated. The comparison is between the Tina-quant Albumin Gen. 2 assay on the cobas c501 analyzer and a nephelometric Albumin test. The sample concentrations were between 5.70 and 100 g/L.
-
CSF Application Method Comparison:
- Sample Size: n = 85
- Provenance: Not explicitly stated. The comparison is between the Tina-quant Albumin Gen. 2 assay on the cobas c501 analyzer and a nephelometric Albumin test. The sample concentrations were between 115 and 2640 mg/L.
-
Precision, Sensitivity, Specificity, Interferences:
- The sample sizes for these internal studies are not explicitly mentioned in the provided text for each specific test, but they are implied to be sufficient for analytical validation. Provenance is also not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- The document describes an in-vitro diagnostic device for quantitative determination of albumin. The "ground truth" here is the actual albumin concentration in the samples, established by reference methods or predicate devices, rather than expert interpretation of images or other subjective data.
- Therefore, the concept of "experts" to establish a subjective ground truth (like radiologists for imaging) is not directly applicable to this type of analytical device. The references are to other cleared devices (predicate devices) or established analytical methods.
4. Adjudication Method for the Test Set
- As the device provides a quantitative measurement, and the "ground truth" is established by a reference method or predicate device performance, there is no mention of an "adjudication method" in the sense of reconciling differences between multiple human interpreters. This concept is typically relevant for subjective assessments (e.g., medical image interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study is relevant for devices that assist human readers (e.g., AI in radiology). The Tina-quant Albumin Gen. 2 assay is a standalone diagnostic test performed by an automated analyzer, not an assistive technology for human interpreters.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, the performance data presented is for the standalone device (Tina-quant Albumin Gen. 2 assay on the Roche/Hitachi cobas c systems) without human intervention for the measurement itself. The results are quantitative values generated by the automated system. The accuracy is assessed by correlation with predicate devices/methods.
7. The Type of Ground Truth Used
- The ground truth for the performance studies (specifically method comparisons) was established by comparison to existing, legally marketed predicate devices or established nephelometric albumin tests. This implies that the predicate devices/methods themselves served as the reference standard for the "true" albumin values in the samples.
8. The Sample Size for the Training Set
- The document describes a 510(k) submission for substantial equivalence. This is for a conventional in-vitro diagnostic (IVD) assay, not a machine learning or AI-based device that typically involves "training sets." Therefore, the concept of a "training set" in the context of machine learning is not applicable here. The assay relies on established immunoturbidimetric principles, and performance is validated through analytical studies on test samples.
9. How the Ground Truth for the Training Set Was Established
- As explained in point 8, the concept of a "training set" is not applicable to this device submission.
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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 Diagnostics9115 Hague RoadIndianapolis, IN 46250Phone: (317) 521 - 3831Fax: (317) 521 - 2324Contact Person: Kathie J. GoodwinDate Prepared: April 23 rd , 2010 |
| Device Name | Proprietary names: Tina-Quant Albumin Gen. 2Common names: Albumin Gen. 2 assayRegulation: 21 CFR 866.5040Classification names: Albumin Immunological Test SystemProduct 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 AssayUrine Application | Predicate Device: HitachiMicroalbumin Urine Assay(K932950) |
|---|---|---|
| Intended Use | In vitro test for the quantitativedetermination of albumin in humanurine, serum, plasma and CSF(albumin CSF/serum ratio) onRoche/Hitachi cobas c systems. | For the quantitative determination oflow levels of albumin in urine(Microalbumin, MAU). |
| Assay Protocol | Immunoturbidimetric | Same |
| Sample Type | Urine | Same |
| LabeledInstrumentPlatform | Roche/Hitachi cobas c analyzer -cobas c501 | Boehringer Mannheim/Hitachi 747analyzer |
| Calibrator | C.f.a.s. PUC | Microalbumin calibrators (included inkit) |
| CalibrationFrequency | Calibrate after reagent lot changeand as required following qualitycontrol procedures | Perform full calibration every twoweeks. |
| Controls | Precinorm PUC and Precipath PUCorPrecinorm Protein and PrecipathProtein | Precinorm Albumin and PrecipathAlbumin |
| Reagent Stability | On-board in use:12 weeks at 2-8 Deg. C | On-board in use:4 weeks at 2-12 Deg. C |
| MeasuringRange | c501:12-400 mg/L | 3 mg/L up to the value of the highestcalibrator |
| 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% | |
| AnalyticalSensitivity | Limit of Blank (LoB) =2 mg/LLimit of Detection (LoD) =3 mg/LLimit of Quantitation (LoQ) =12 mg/L | Lower Detection Limit = 3 mg/L |
| AnalyticalSpecificity | No interference was found atcommon therapeutic concentrationsusing common drug panels.Due to the antigen excess checkreagent R3, no unflagged high-dosehook effect will occur up to analbumin concentration of 40000mg/L. | No interference was observed from 18common drugs. |
| Note: calibrator values were lotspecific. In one representative lot,values (mg/L) were:Cal 3a: 0.0Cal 3b: 10.5Cal 3c: 62.6Cal 3d: 154.0Cal 3e: 347.0 | ||
| Interferences | Criterion: Recovery within ± 10% | No significant interference observed fromcalcium levels up to 100 mg/dL. |
| Icterus: no significant interference upto an I index of 50 (approximateconjugated bilirubin concentration: 50mg/dL) | Icterus: no significant interference frombilirubin up to 25 mg/dL. | |
| Hemolysis: No significant interferenceup to an H index of 400 (approximatehemoglobin concentration: 400 mg/dL) | Hemolysis: Hemoglobin levels >300mg/dL cause significant positiveinterference. | |
| No interference by acetone ≤ 60mmol/L, ammonia chloride ≤0.11mol/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 andurobilinogen ≤378 umol/L. | Lipemia (Intralipid): No significantinterference up to an L index of 200.There is poor correlation between the Lindex (corresponds to turbidity) andtriglyceride concentration. | |
| Expected Values | 2nd morning urine:Adults:<20 mg albumin/g creatinine or<2.26 g albumin/mol creatinineChildren (3-5 years):<20 mg/L albumin<37 mg albumin/g creatinine | 2nd morning urine:Adults:sameChildren (3-5 years):same |
| 24 hour urine:<20 mg/L<30 mg/24 h | 24 hour urine:Microalbuminuria: 30-300 mgalbumin/24 hr | |
| MethodComparisons | A comparison of the Roche Tina-quant Albumin Gen. 2 assay on the c501analyzer(x) with the Hitachi Microalbumin assay on the Hitachi 917 analyzer(K953239) (y) gave the following correlation: | |
| Passing Bablocky = 1.023x + 3.64 mg/L$\tau$ = 0.984 | Linear Regressiony = 1.028x - 4.13 mg/Lr = 0.999 | |
| n = 125Sample concentrations were between 12.3 and 386 mg/L |
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| Substantialequivalence -comparisonFeature | Tina-quant Albumin Gen. 2 AssaySerum/Plasma Application | Predicate Device: Behring NAntiserum to Human AlbuminAssay (K972929) | |
|---|---|---|---|
| Intended Use | In vitro test for the quantitativedetermination of albumin in humanurine, serum, plasma and CSF(albumin CSF/serum ratio) onRoche/Hitachi cobas c systems. | ||
| Assay Protocol | Immunoturbidimetric | Same | |
| Sample Type | SerumPlasma: Li-heparin and K2-EDTA | Serum | |
| LabeledInstrumentPlatform | Roche/Hitachi cobas c analyzer –cobas c501 | BN Systems | |
| Calibrator | C.f.a.s. PUC | N Protein Standard SL (human) | |
| Calibrationfrequency | Full calibration is recommended afterreagent lot change and as requiredfollowing quality control procedures. | Same | |
| Controls | Precinorm PUC and Precipath PUCorPrecinorm Protein and PrecipathProtein | N/T Protein Controls SL/L, M and HorN/T Protein Control LC | |
| MeasuringRange | c501:3 – 101 g/L | Reference curves are generated bymulti-point calibration. Serialdilutions on N Protein Standard SLare automatically prepared by theinstrument 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% | |
| AnalyticalSensitivity | Limit of Blank (LoB) = 1 g/dLLimit of Detection (LoD) = 2 g/dLLimit of Quantitation (LoQ) = 3 g/dL | Established by the lower limit of thereference curve and dependstherefore upon the concentrations ofthe proteins in the N ProteinStandard SL. | |
| AnalyticalSpecificity | No interference was found at commontherapeutic concentrations usingcommon drug panels. | No interference from commonly useddrugs is known. | |
| Interferences | Criterion: Recovery within ± 10%Icterus: no significant interference up toan I index of 60 (approximate conjugatedbilirubin concentration: 60 mg/dL)Hemolysis: No significant interferenceup to an H index of 1000 (approximatehemoglobin concentration: 1000 mg/dL)Lipemia: No significant interference upto an L index of 1500 (approximateIntralipid concentration: 1500 mg/dL).There is poor correlation between theIntralipid concentration (corresponds toturbidity) and triglycerides concentration.Rheumatoid factors ≤ 1200 IU/mL do notinterfere. | Turbidity and particles in the samplemay interfere with the determination.Therefore, samples containing particlesmust be centrifuged prior to testing.Bovine serum albumin in the sample(e.g. control sample) may disturb thedetermination. | |
| 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 toTietz: | |||
| 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 |
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:
Substantial
equivalence –
comparison
،
| Feature | Tina-quant Albumin Gen. 2 AssayCSF Application | Predicate Device: Behring NAntiserum to Human AlbuminAssay (K972929) |
|---|---|---|
| Intended Use | In vitro test for the quantitativedetermination of albumin in humanurine, serum, plasma and CSF(albumin CSF/serum ratio) onRoche/Hitachi cobas c systems. | In vitro diagnostic reagent for thequantitative determination ofalbumin, prealbumin (transthyretin)and retinol-binding protein (RbP) inhuman serum as well as of albuminin human urine and cerebrospinalfluid (CSF) using the BN Systems |
| Assay Protocol | Immunoturbidimetric | Same |
| Sample Type | CSF | Same |
| LabeledInstrumentPlatform | Roche/Hitachi analyzer - cobas c501 | BN Systems |
:
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| Calibrator | C.f.a.s. PAC | N Protein Standard SL (human) |
|---|---|---|
| Controls | Commercially available control | N/T Protein Controls SL/L, M and HorN/T Protein Control LC |
| MeasuringRange | c501:95 - 3000 mg/L | Reference curves are generated bymulti-point calibration. Serialdilutions on N Protein Standard SLare automatically prepared by theinstrument 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 |
| AnalyticalSensitivity | Limit of Blank (LoB) = 20 mg/LLimit of Detection (LoD) = 36 mg/LLimit of Quantitation (LoQ) = 95 mg/L | Established by the lower limit of thereference curve and dependstherefore upon the concentrations ofthe proteins in the N ProteinStandard SL. |
| AnalyticalSpecificity | No interference was found at commontherapeutic concentrations usingcommon drug panels. | No interference from commonly useddrugs is known. |
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| Interferences | Criterion: Recovery within ± 10% | Not specified for CSF. |
|---|---|---|
| Hemolysis: No significant interferenceup to an H index of 1000 (approximatehemoglobin concentration: 1000 mg/dL) | ||
| Icterus: No significant interference up toan I index 60 (approximate conjugatedand unconjugated bilirubin concentration:600 mg/L) | ||
| High dose hook-effect: Using theprozone check, no false result without aflag was observed up to an albuminconcentration 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 |
| MethodComparisons | A comparison of the Roche Tina-quant Albumin Gen. 2 assay on the cobasc501 analyzer(x) with the nephelometric Albumin test gave the followingcorrelation: | |
| 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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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
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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
Page 1 of 1
§ 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.