(85 days)
The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
The Preciset Lp(a) calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
The TQ Lp(a) Gen.2 test principle is a particle-enhanced immunoturbidimetric assay. Human lipoprotein (a) agglutinates with latex particles coated with anti-Lp(a) antibodies. The precipitate is determined turbidimetrically. The Preciset Lp(a) Gen.2 calibrator set consists of five lyophilized calibrators based on a stabilized and lyophilized pool of human plasma. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. The PreciControl Lp(a) Gen.2 control set contains two lyophilized controls based on a human plasma matrix.
Here's a summary of the acceptance criteria and study information for the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device and reports performance characteristics rather than explicit acceptance criteria. However, we can infer some criteria from the comparative data and the general performance evaluation.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate/Good Practice) | Reported Device Performance (TQ Lp(a) Gen.2 assay) |
|---|---|---|
| Measuring Range | Comparable to predicate (2.0 – 80.0 mg/dL) | 6.0 – 80.0 mg/dL |
| Lower Limits of Measure | LDL: 2.0 mg/dL (predicate) | LoB: 3 mg/dL, LoD: 4 mg/dL, LoQ: 6 mg/dL |
| Hook Effect | No significant effect within expected range | No hook effect up to 190 mg/dL |
| Precision (Within-run) | Comparable to predicate or better | Control L: 1.4% CV, Control H: 1.0% CV |
| Pool 1: 5.4% CV, Pool 2: 6.2% CV | ||
| Pool 3: 2.4% CV, Pool 4: 0.9% CV | ||
| Precision (Intermediate/Total) | Comparable to predicate or better | Control L: 1.6% CV, Control H: 1.1% CV |
| Pool 1: 7.6% CV, Pool 2: 6.4% CV | ||
| Pool 3: 2.9% CV, Pool 4: 1.1% CV | ||
| Icterus Interference | No significant interference | No significant interference up to an I index of 60 (approx. 60 mg/dL) |
| Hemolysis Interference | No significant interference | No significant interference up to an H index of 1000 (approx. 1000 mg/dL) |
| Lipemia Interference | No significant interference | No significant interference up to an L index of 2000 |
| Plasminogen Cross-Reactivity | No significant cross-reactivity | No significant cross-reactivity up to 150 mg/dL |
| Apolipoprotein B Cross-Reactivity | No significant cross-reactivity | No significant cross-reactivity up to 200 mg/dL |
| Rheumatoid Factor Interference | Not specified for predicate | No significant interference up to 1200 IU/mL |
| Drugs Interference | Not specified for predicate | No interference at therapeutic concentrations using common drug panels |
| Reagent On-board Stability | Stable for a reasonable period | 6 weeks |
| Reagent Unopened Stability | Stable until expiration date | 2-8°C until expiration date |
| Calibration Frequency | After reagent lot change and as required | Same |
Study Proving Acceptance Criteria:
The document describes the submission as a 510(k) premarket notification, indicating a substantial equivalence study. The study's purpose is to demonstrate that the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System (candidate device) is as safe and effective as a legally marketed predicate device. This is primarily achieved through direct comparison of features and performance characteristics, as summarized in the tables provided in the document. The document lists "Evaluations summary" in Section 9, indicating that performance characteristics were evaluated.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., precision, interference studies, linearity, method comparison). It mentions evaluating "several performance characteristics."
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It is implied to be laboratory-generated data for performance evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the evaluation of an in vitro diagnostic (IVD) device like the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System. The "ground truth" for these tests is established by reference methods or accepted analytical principles, not by expert consensus in the same way it would be for, for example, image interpretation. The device measures a specific analyte concentration.
4. Adjudication Method for the Test Set
Not applicable for this type of IVD device. Analytical performance is typically evaluated against defined statistical metrics and analytical specifications, not through 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 device for quantitative measurement of a biomarker, not an AI-assisted diagnostic imaging or interpretation system involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an IVD assay, so its performance is inherently "standalone" in terms of measurement. The "algorithm" here refers to the immunoassay chemistry and detection system. Its performance is evaluated independently of human interpretation of raw signals, although human operators perform the testing and interpret the final quantitative results.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device would be established by:
- Reference materials/calibrators: The Preciset Lp(a) Gen.2 calibrator set is mentioned as being based on a "stabilized and lyophilized pool of human plasma," with concentrations adjusted for optimal calibration. This implies traceability to a higher-order reference method or material for determining Lp(a) concentrations.
- Method comparison against predicate device: The substantial equivalence comparison implies that the predicate device serves as a benchmark for acceptable performance.
- Physiological samples with known characteristics: For interference studies, samples spiked with known interferents would be used.
8. The Sample Size for the Training Set
No information is provided about a "training set" in the context of machine learning. For an IVD assay, method development involves extensive experimentation for optimization of reagents, reaction conditions, and calibration models. However, these are not typically referred to as "training sets" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable for a chemical immunoassay, as there is no machine learning "training set" in the conventional sense. The "ground truth" for assay development and validation is established through analytical chemistry principles, use of reference materials, and comparison to established methods.
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NDV 2 9 2012
1
| Section 4 - 510(k) Summary: cobas c Tina-quant Lipoprotein (a)Gen.2 Test System | ||
|---|---|---|
| Purpose | In accordance with 21 CFR 807.87, Roche Diagnostics hereby submitsofficial notification as required by Section 510(k) of the Federal Food, Drugand Cosmetics Act of our intention to market the device described in thisPremarket Notification [510(k)]. | |
| The purpose of this premarket notification is to obtain FDA review andclearance for the cobas c Tina-quant Lipoprotein (a) Gen.2 assay, PrecisetLp(a) Gen.2 calibrator set, and PreciControl Lp(a) Gen.2 control set. | ||
| Device name | Proprietary name: | (1) cobas c Tina-quant Lipoprotein (a) Gen.2 assay(2) Preciset Lp(a) Gen.2 calibrator set(3) PreciControl Lp(a) Gen.2 control set |
| Common name: | (1) TQ Lp(a) Gen.2(2) Preciset Lp(a) Gen.2 calibrator set(3) PreciControl Lp(a) Gen.2 control set | |
| Classification: | (1) Low-Density Lipoprotein Immunological Test System(2) Calibrator, secondary(3) Single (specified) analyte controls (assayed andunassayed) | |
| Establishmentregistration | For the cobas c Tina-quant Lipoprotein (a) Gen.2 assay, Preciset Lp(a) Gen.2calibrator set, and PreciControl Lp(a) Gen.2 control set, the establishmentregistration number for Roche Diagnostics GmbH in Mannheim, Germany is9610126. The establishment registration number for Roche DiagnosticsUnited States is 1823260. |
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| Classification | The FDA has classified the Low-Density Lipoprotein Immunological TestSystem (TQ Lp(a) Gen.2) and the calibrator (Preciset Lp(a)) as Class IIdevices.The FDA has classified the single (specified) analyte controls (assayed andunassayed) (PreciControl Lp(a)) as a Class 1 (reserved) device. | |||||
|---|---|---|---|---|---|---|
| Panel | ProductCode | Classification Name | Regulation | |||
| ClinicalChemistry | DFC | Low-Density LipoproteinImmunological Test System | 21 CFR866.5600 | |||
| ClinicalChemistry | الا | Calibrator, secondary | 21 CFR862.1150 | |||
| ClinicalChemistry | الا ال | Single (specified) analyte controls(assayed and unassayed) | 21 CFR862.1660 | |||
| Performancestandards | To date, no performance standards that affect this device have been finalizedunder Section 514 of the Act.Draft labeling sufficient to describe the device, its intended use, and thedirections for use on the cobas c 501 analyzer is attached. We believe thedraft version of the device labeling presented in Section 8 contains all of thetechnical information required per 21 CFR 809.10 for the cobas c Tina-quantLipoprotein (a) Gen.2 test system. | |||||
| Proposedlabeling | ||||||
| Continued on next page |
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The TQ Lp(a) Gen.2 test principle is a particle-enhanced Device description immunoturbidimetric assay. Human lipoprotein (a) agglutinates with latex particles coated with anti-Lp(a) antibodies. The precipitate is determined turbidimetrically. The Preciset Lp(a) Gen.2 calibrator set consists of five lyophilized calibrators based on a stabilized and lyophilized pool of human plasma. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. The PreciControl Lp(a) Gen.2 control set contains two lyophilized controls based on a human plasma matrix. Intended cobas c Tina-quant Lipoprotein (a) Gen.2 assay: use/indications The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test for use intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma the Roche/Hitachi cobas c 501 analyzer. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. Preciset Lp(a) Gen.2 calibrator set: The Preciset Lp(a) Gen.2 calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. PreciControl Lp(a) Gen.2 control set: The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. Continued on next page
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| Substantialequivalence | The cobas c Tina-quant Lipoprotein (a) Gen.2 Test System is substantiallyequivalent to other devices legally marketed in the United States. |
|---|---|
| (1) cobas c Tina-quant Lipoprotein (a) Gen.2 assay is equivalent to Lp(a)-Latex SEIKEN assay, Denka Seiken Co., Ltd. (K013359). | |
| (2) Preciset Lp(a) Gen.2 calibrator set is equivalent to the Diazyme Lp(a)calibrator set, General Atomics (K082488). | |
| (3) PreciControl Lp(a) Gen.2 control set is equivalent to the DiazymeLp(a) control set, General Atomics (K082488). | |
| Substantialequivalence -comparison | The following tables compare the cobas c Tina-quant Lipoprotein (a) Gen.2assay, Preciset Lp(a) Gen.2 calibrator set, and PreciControl Lp(a) Gen.2control set with their respective predicate devices. |
| Continued on next page |
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Comparison of assays similarities and differences
| Feature | Assay Comparison | TQ Lp(a) Gen.2 assay |
|---|---|---|
| Lp(a)-Latex Seiken assay(predicate device: K013359) | (candidate device) | |
| IntendedUse/Indicationsfor Use | The Lp(a)-Latex Seiken Assaykit is an in vitro diagnostic testfor the quantitativedetermination of lipoprotein(a)[Lp(a)] in huma serum andplasma samples using Hitachi917 analyzer. The measurementof Lp(a) is useful in evaluatinglipid metabolism disorders andassessing atheroscleroticcardiovascular disease in specificpopulations, when used inconjunction with clinicalevaluation and other lipoproteintests. | The cobas c Tina-quantLipoprotein (a) Gen.2 assay isan in vitro test intended for thequantitative determination oflipoprotein(a) [Lp(a)] inhuman serum and plasma theRoche/Hitachi cobas c 501analyzer. The measurement ofLp(a) is useful in evaluation oflipid metabolism disorders andassessing atheroscleroticcardiovascular disease inspecific populations, whenused in conjunction withclinical evaluation and otherlipoprotein tests. |
| Assay principle | immunoturbidimetric | same |
| Sample types | Human serum and Na2-EDTA,K2-EDTA, Na-heparin, Li-Heparin, and Citric acid plasma | Human serum and K2-EDTA,K3-EDTA, and Li-Heparin |
| InstrumentPlatform | Roche/Hitachi 917 analzyer | cobas c 501 analyzer |
| Calibrator | Lp(a)-Latex Seiken Assay KitCalibrators | Preciset Lp(a) Gen.2 calibratorset |
| CalibrationFrequency | After reagent lot change and asrequired following qualitycontrol procedures. | same |
| Calibrationmode | Six point; spline | same |
| Controls | commercially available controls | PreciControl Lp(a) control set(2 levels) |
| Reagent activeingredients | R1: glycine buffer solutionR2: latex particles with anti- | R1: glycine buffer solutionR3: latex particles with anti- |
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| Comparison ofassays –similarities anddifferences(continued) | Assay Comparison | ||
|---|---|---|---|
| Feature | Lp(a)-Latex Seiken assay(predicate device: K013359) | TQ Lp(a) Gen.2 assay(candidate device) | |
| ReagentStability | Unopened:2-10°C until expiration date | Unopened:2-8°C until expiration date | |
| On-board in use:N/A | On-board in use:6 weeks | ||
| Measuringrange | 2.0 – 80.0 mg/dL | 6.0 – 80.0 mg/dL | |
| LowerLimits ofMeasure | LDL: 2.0 mg/dLLoB, LoD, and LoQ not tested | LDL: not testedLoB: 3 mg/dLLoD: 4 mg/dLLoQ: 6 mg/dL | |
| Hook Effect | Not tested | No hook effect up to 190mg/dL | |
| ExpectedValues | cutoff point: 30 mg/dLReference ranges have not beenestablished for this assay fordifferent ethnic populations ordisease states. Since Lp(a)levels are largely influenced byhereditary factors and vary withethnic populations, it isrecommended that eachlaboratory establish its ownexpected values. | same |
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| Comparison ofassays -similarities anddifferences(continued) | Feature | Assay Comparison | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Precision | Lp(a)-Latex Seiken assay(predicate device: K013359) | TQ Lp(a) Gen.2 assay(candidate device)Repeatability = Within-run precision: | |||||||
| Within-run precision: | Mean | SD | CV | ||||||
| Control I | 21.9 mg/dL | 0.438 | 2.00% | Control L | 20.3 mg/dL | 0.3 | 1.4% | ||
| Control II | 54.7 mg/dL | 0.686 | 1.26% | Control H | 61.5 mg/dL | 0.6 | 1.0% | ||
| Pool 1 | 7.0 mg/dL | 0.4 | 5.4% | ||||||
| Pool 2 | 16.1 mg/dL | 1.0 | 6.2% | ||||||
| Pool 3 | 30.9 mg/dL | 0.7 | 2.4% | ||||||
| Pool 4 | 79.4 mg/dL | 0.7 | 0.9% | ||||||
| Between-run precision: | Intermediate Precision = Total precision/Between-run precision | ||||||||
| Mean | SD | CV | Mean | SD | CV | ||||
| Control I | 18.7 mg/dL | 0.40 | 2.12% | Control L | 20.3 mg/dL | 0.3 | 1.6% | ||
| Control II | 41.5 mg/dL | 0.44 | 1.06% | Control H | 61.5 mg/dL | 0.7 | 1.1% | ||
| Pool 1 | 8.4 mg/dL | 0.19 | 2.22% | Pool 1 | 7.0 mg/dL | 0.5 | 7.6% | ||
| Pool 2 | 26.5 mg/dL | 0.29 | 1.11% | Pool 2 | 16.1 mg/dL | 1.0 | 6.4% | ||
| Pool 3 | 66.3 mg/dL | 0.66 | 0.99% | Pool 3 | 30.9 mg/dL | 0.9 | 2.9% | ||
| Pool 4 | 79.4 mg/dL | 0.9 | 1.1% |
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| Feature | Lp(a)-Latex Seiken assay(predicate device: K013359) | TQ Lp(a) Gen.2 assay(candidate device) |
|---|---|---|
| Interferencesand crossreactivity | Icterus (conjugated andunconjugated bilirubin):no significant interference upto 30 mg/dL | Icterus (conjugated andunconjugated bilirubin):no significant interference upto an I index of 60(approximately 60 mg/dL) |
| Hemolysis:no significant interference upto 500 mg/dL | Hemolysis:no significant interference upto an H index of 1000(approximately 1000 mg/dL) | |
| Triglycerides:no significant interference upto 1500 mg/dL | Lipemia:no significant interference upto an L index of 2000 | |
| Plasminogen:no significant interference upto 200 mg/dL | Plasminogen:no significant crossreactivity up to 150 mg/dL | |
| Apolipoprotein B:no significant interference upto 200 mg/dL | Apolipoprotein B:no significant crossreactivity up to 200 mg/dL | |
| Rheumatoid Factor:no significant interference upto 1200 IU/mL | ||
| Drugs:No interference was found attherapeutic concentrationsusing common drug panels |
Continued on next page
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Comparison of calibrators – similarities and differences
| Calibrator Comparison | ||
|---|---|---|
| Feature | Diazyme Lp(a) calibrator(predicate device: K082488) | Preciset Lp(a) Gen.2calibrator set(candidate device) |
| Intendeduse | The Diazyme Lp(a)calibrator set is intended foruse in establishing thecalibration curve for theDiazyme Lp(a) reagents byturbidimetry. | The Preciset Lp(a) Gen.2calibrator set is intended for usein the calibration ofquantitative Roche methods onRoche clinical chemistryanalyzers as specified in thevalue sheets. |
| Analyte | Lipoprotein (a) | same |
| Format &matrix | Consists of 5 lyophilizedhuman serum calibrators | Consists of 5 lyophilizedhuman plasma calibrators |
| Storage | 2-8°C | same |
Comparison of controls – similarities and differences
| Control Comparison | ||
|---|---|---|
| Feature | Diazyme Lp(a) control set(predicate device: K082488) | PreciControl Lp(a) Gen.2control set(candidate device) |
| Intendeduse | The Diazyme control set isintended for use inmonitoring the qualitycontrol of results obtainedwith the Diazyme Lp(a)reagents by turbidimetry. | The PreciControl Lp(a) Gen.2control set is intended for usein quality control bymonitoring accuracy andprecision for the quantitativemethods as specified in thevalue sheets. |
| Analyte | Lipoprotein (a) | same |
| Format &matrix | Consists of 2 lyophilizedhuman serum controls | Consists of 2 lyophilizedhuman plasma controls |
| Storage | 2-8°C | same |
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| Evaluationssummary | (1) The cobas c Tina-quant Lipoprotein (a) Gen.2 assay was evaluated forseveral performance characteristics, including precision, LoB, LoD,LoQ, high dose hook effect, cross reactivity, method comparison,interfering substances, anticoagulants, linearity, reagent on-boardstability, and reagent shelf life stability. |
|---|---|
| (2) The Preciset Lp(a) calibrator set was evaluated for value assignmentand stability. | |
| (3) The PreciControl Lp(a) control set was evaluated for value assignmentand stability. | |
| A summary of the evaluation studies is provided in Section 5-AnalyticalPerformance Characteristics. | |
| Confidentiality | Roche Diagnostics requests that the FDA not disclose the nature or existenceof the premarket notification until the substantial equivalence decision hasbeen reached. |
| Closing | We trust that the information provided in this Premarket Notification [510(k)]will support a determination of substantial equivalence for the cobas c Tina-quant Lipoprotein (a) Gen.2 test system. |
| If you should have questions or required further information, please do nothesitate to contact this office. | |
| Lisa K. KlinedinstRoche DiagnosticsRegulatory Affairs ConsultantPhone: 317-521-1942Fax: 317-521-2324 | |
| Date prepared: November 28, 2012 |
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Image /page/10/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The seal is simple, using only black and white, and is designed to convey the department's mission of promoting health and well-being.
DEPARTMENT OF HEALTH & HUM AN SERVICES
Public Health Service .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 29, 2012
Roche Diagnostics c/o Lisa K. Klinedinst 9115 Hague Road, Building A Indianapolis, IN 46250-0416
Re: K122722
Trade/Device Name: cobas c Tina-quant Lipoprotein (a) Gen.2 Test System
Preciset Lp(a) Gen.2 calibrator set
PreciControl Lp(a) Gen.2 control set
Regulation Number: 21 CFR 866.5600
Regulation Name: Low Density Lipoprotein Immunological Test System Regulatory Class: Class II Product Code: DFC, JIT, JJX Dated: August 31, 2012 Received: September 5, 2012
Dear Ms. Klinedinst:
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Lisa Klinedinst
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Diagnostics and Radiological Health 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,
Carol C. Benson for
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122722
.Device Name: cobas c Tina-quant Lipoprotein (a) Gen.2 Test System Preciset Lp(a) Gen.2 calibrator set
PreciControl Lp(a) Gen.2 control set
Indications for Use:
The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for The countitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is plasma on the Rooms/Filipid metabolism disorders and assessing atherosclerotic useful in evaluation of ifpla metas oppulations, when used in conjunction with clinical evaluation and other lipoprotein tests.
The Preciset Lp(a) calibrator set is intended for use in the calibration of The I reciser Ep(d) canorator books clinical chemistry analyzers as specified in the value sheets.
The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by The I recreonifor Ep(d) Goll:2 com:2 comfor the quantitative methods as specified in the value sheets.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 Diagnostics and Radiological Health (OIR)
Ruth A. Chesler
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K122722 510(k)
§ 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).