(49 days)
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein B in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
Human apolipoprotein B forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
Here's a summary of the acceptance criteria and study information for the Tina-quant Apolipoprotein B ver.2 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" for each performance characteristic. However, we can infer the performance of the predicate device as a benchmark against which the new device is compared. The reported performance for the new device and the predicate are listed.
| Feature | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Tina-quant Apolipoprotein B ver.2) |
|---|---|---|
| Precision | Within run CV: 0.66% @ 1.30 g/L, 0.50% @ 2.22 g/L Total CV: 2.1% @ 1.30 g/L, 0.98% @ 2.22 g/L | Within run CV: 1.2% @ 0.8 g/L, 1.1% @ 1.5 g/L Between Day CV: 2.9% @ 0.8 g/L, 3.2% @ 1.5 g/L |
| Method Comparison | Correlation to a commercially available system (X): y = 1.06x + 0.10 g/L, r = 0.983 (Bablok/Passing) | Correlation to COBAS Integra Apolipoprotein B (X): y = 1.02x + 0.03 g/L, r = 0.954 (Bablok/Passing) |
| Prozone Effect | No effect up to 19.8 g/L | No effect up to 6 g/L |
| Analytical Sensitivity (LDL) | Determined by the lower limit of the standard curve; typical concentration approximately 0.26 g/L | 0.046 g/L |
| Limitations (Interferences) | Icterus: No significant interference Hemolysis: No significant interference Lipemia: No significant interference Rheumatoid factors: Levels > 300 IU/ml slightly increase apparent concentration | Icterus: No significant interference Hemolysis: No significant interference Lipemia: No significant interference up to an Intralipid level of 1000 mg/dL Rheumatoid factors: No significant interference |
| Measuring Range | 0.26 - 3.9 g/L (0.09 - 7.8 g/L with rerun) | 0.20 - 4.0 g/L (0.10 - 4.0 g/L with rerun) |
| Reagent Stability (On-board) | 12 weeks | 4 weeks |
| Expected Values (Females) | 0.50 - 1.30 g/L | 0.60 - 1.17 g/L |
| Expected Values (Males) | 0.60 - 1.40 g/L | 0.66 - 1.33 g/L |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the sample size used for the method comparison or precision studies. It only presents the results (e.g., CV values, regression parameters).
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in vitro diagnostic reagent system designed to quantitatively measure apolipoprotein B. The concept of "experts" establishing ground truth for individual cases, as might be done in image analysis or clinical diagnosis, is not applicable here. The "ground truth" for method comparison would typically be the results obtained from a reference method or a predicate device, as indicated in the "Method Comparison" section where the Tina-quant Apolipoprotein B ver.2 (Y) is compared to the COBAS Integra Apolipoprotein B (X).
4. Adjudication method for the test set:
Not applicable. As described above, this is a quantitative measurement device, not one requiring expert adjudication of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an in vitro diagnostic assay, not a device involving human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a standalone in vitro diagnostic reagent system. Its performance characteristics (precision, method comparison, analytical sensitivity, etc.) are inherent to the assay and instrument system, operating without human interpretation other than performing the test and reviewing the quantitative result.
7. The type of ground truth used:
- For Method Comparison, the "ground truth" for the new device was established by comparing its results to those obtained from the predicate device (COBAS Integra Apolipoprotein B), which is established technology. For the predicate device's own method comparison, it was compared to a "commercially available system." This suggests established, validated methods are used as a comparative standard.
- For Precision, the ground truth is the statistical variation around the measured concentration.
- For Analytical Sensitivity, it's determined through laboratory testing procedures.
- For Interference studies, known concentrations of interfering substances are added to samples, and the results are compared to non-interfered samples.
8. The sample size for the training set:
Not applicable. This is a chemical/immunological assay, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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NOV 1 3 2001
: :
| 510(k) Summary | K013207 |
|---|---|
| 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 Corporation 9115 Hague Road Indianapolis, IN 46250 (317) 521 - 3544 |
| Contact Person: Kay A. Taylor | |
| Date Prepared: September 24, 2001 | |
| Device Name | Proprietary name: Tina-quant Apolipoprotein ver.2 |
| Common name: Apolipoprotein B | |
| Classification name: Low-density lipoprotein immunological test system | |
| Device Description | Human apolipoprotein B forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm. |
| Intended use | In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein B in serum and plasma. |
| Indications for Use | For the quantitative determination of apolipoprotein B in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis. |
:
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510(k) Summary, Continued
The Tina-quant Apolipoprotein B ver.2 is substantially equivalent to other Substantial devices legally marketed in the United States. We claim equivalence to the Equivalence COBAS Integra Tina-quant Apolipoprotein B (K990595).
Substantial equivalence similarities
The following table compares the Tina-quant Apolipoprotein B ver.2 Assay with the predicate device.
| Feature | Tina-quantApolipoprotein B ver.2 | Apolipoprotein B(predicate) |
|---|---|---|
| Intended Use | In vitro diagnostic reagentsystem intended for use onCOBAS INTEGRA systemfor the quantitativeimmunologicaldetermination of humanapolipoprotein B in serumand plasma. | In vitro diagnostic reagentsystem intended for use onCOBAS Integra (analyzermodel) for the quantitativeimmunological determinationof human apolipoprotein B inserum and plasma. |
| Indication forUse | For the quantitativedetermination ofapolipoprotein B in serumand plasma. A lipoproteintest system is a deviceintended to measurelipoprotein in serum andplasma. Lipoproteinmeasurements are used inthe diagnosis and treatmentof lipid disorders andatherosclerosis. | For the quantitativedetermination ofapolipoprotein B in serumand plasma. A lipoproteintest system is a deviceintended to measurelipoprotein in serum andplasma. Lipoproteinmeasurements are used in thediagnosis and treatment oflipid disorders andatherosclerosis. |
| Assay Protocol | Immunoturbidometric | Immunoturbidometric |
| Instrument | COBAS Integra ClinicalChemistry Analyzers | COBAS Integra ClinicalChemistry Analyzers |
| Traceability /Standardization | Standardized with regard tothe IFCC referencepreparation SP3-07. | Standardized with regard tothe IFCC referencepreparation SP3-07. |
| Sample Type | Serum and plasma | Serum and plasma |
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510(k) Summary, Continued
| Feature | Tina-quant ApolipoproteinB ver.2 | Apolipoprotein B(predicate) |
|---|---|---|
| CalibrationInterval | After each lot | After each lot |
| Formulation | R: TRIS buffer,polyethylene glycol,detergent, preservative(liquid).SR: Anti-apolipoprotein Bantibody (sheep) specific forhuman Apo B, TRIS buffer,preservative (liquid). | R: Anti-apolipoprotein B Tantiserum (rabbit) specific forhuman Apo B, in phosphatebuffer stabilized with 0.09%sodium azide in vial A(liquid). |
Substantial equivalence —
differences
The following table compares the Tina-quant Apolipoprotein B ver.2 Assay with the predicate device.
| Feature | Tina-quant ApolipoproteinB ver.2 | Apolipoprotein B(predicate) |
|---|---|---|
| ReagentStability | On board: 4 weeks | On-board: 12 weeks |
| Calibrator | C.f.a.s. Lipids | Apolipoprotein T Standard |
| Controls | Precinorm L, Precipath L | Apolipoprotein T Control |
| ExpectedValues | Females: 0.60 - 1.17 g/LMales: 0.66 - 1.33 g/L | Females: 0.50 - 1.30 g/LMales: 0.60 - 1.40 g/L |
| MeasuringRange | 0.20 - 4.0 g/L(0.10 - 4.0 g/L with rerun) | 0.26 - 3.9 g/L(0.09 - 7.8 g/L with rerun) |
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510(k) Summary, Continued
Substantial equivalence performance characteristics The performance characteristics of the Tina-quant Apolipoprotein B ver.2 The performance dicate device are compared in the table below.
| Feature | Tina-quant Apolipoprotein B ver.2 | Apolipoprotein B (predicate) |
|---|---|---|
| Precision | Within run CV1.2% @ 0.8 g/L1.1% @ 1.5 g/LBetween Day CV2.9% @ 0.8 g/L3.2% @ 1.5 g/L | Within run CV0.66% @ 1.30 g/L0.50% @ 2.22 g/LTotal CV2.1% @ 1.30 g/L0.98% @ 2.22 g/L |
| Method Comparison | Bablok/Passing:Tina-quant Apolipoprotein B ver.2 (Y) / COBAS Integra Apolipoprotein B (X).y = 1.02x + 0.03 g/Lr = 0.954 | Bablok/Passing:Apolipoprotein B (Y)/ commercially available system (X).y = 1.06x + 0.10 g/Lr = 0.983 |
| Prozone Effect | No effect up to 6 g/L | No effect up to 19.8 g/L |
| Analytical sensitivity (LDL) | 0.046 g/L | Determined by the lower limit of the standard curve which varies with the Apo B concentration of the calibrator. Typical concentration approximately 0.26 g/L |
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Premarket Notification, 510(k) for Tina-quant Apolipoprotein B ver. 2 Test System on COBAS Integra Clinical Chemistry Analyzers, continued
Substantial equivalence performance characteristics, cont.
The performance characteristics of the Tina-quant Apolipoprotein B ver.2 Assay and the predicate device are compared in the table below.
| Feature | Tina-quant ApolipoproteinB ver.2 | Apolipoprotein B |
|---|---|---|
| Limitations | • Icterus: No significantinterference• Hemolysis: Nosignificant interference• Lipemia: No significantinterference up to anIntralipid level of 1000mg/dL• Rheumatoid factors: Nosignificant interference | • Icterus: No significantinterference• Hemolysis: Nosignificantinterference• Lipemia: Nosignificantinterference• Rheumatoid factors:Levels of rheumatoidfactors higher than300 IU/ml increasethe apparentapolipoprotein Bconcentration slightly. |
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 2001
Ms. Kay A. Taylor Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K013207 Re:
Trade/Device Name: Tina-quant Apolipoprotein B ver.2 Regulation Number: 21 CFR 866.5600 Regulation Name: Low density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC Dated: September 24, 2001 Received: September 25, 2001
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use Stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce provided to May 20, 1978, as condance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmette Act (rear the device, subject to the general controls provisions of the Act. The T ou may, therefore, mains of the Act include requirements for annual registration, listing of general controll pro resuring 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 If your device is classined (600 a00 rols. Existing major regulations affecting your device can may be subject to success reculations, Title 21, Parts 800 to 898. In addition, FDA may or found in the Outsting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc ac now that i Dr over device complies with other requirements of the Act that I Dri has intass and regulations administered by other Federal agencies. You must of any I cacial stututes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I all 6077, laoomig (21 CFR Part 820); and if applicable, the electronic form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noalicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NOV 1 3 2001
Indications for Use Statement
K013207 510(k) Number (if known): N/A
Device Name: Tina-quant Apolipoprotein B ver.2
Indications For Use:
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the In vitro diagnostic rougent by ecommination of human apolipoprotein B in serum and plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and A npoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
e un Cooper
. vices ion of Clinical Lal 510(k) Number
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).