(85 days)
Not Found
No
The device description and performance studies focus on standard immunoturbidimetric assay principles and analytical performance characteristics, with no mention of AI or ML.
No
This device is an in vitro diagnostic test used for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma to evaluate lipid metabolism disorders and assess atherosclerotic cardiovascular disease. It is a diagnostic tool, not a therapeutic device.
Yes
The device quantitatively determines lipoprotein(a) [Lp(a)] which is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease, indicating its use in diagnosing health conditions.
No
The device description clearly states it is an "in vitro test" and describes physical components like "latex particles coated with anti-Lp(a) antibodies," "lyophilized calibrators based on a stabilized and lyophilized pool of human plasma," and "lyophilized controls based on a human plasma matrix." These are all hardware/reagent components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for the quantitative determination of lipoprotein(a) in human serum and plasma. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the test principle (particle-enhanced immunoturbidimetric assay) and the components (reagents, calibrators, controls) used to perform the test on human samples.
- Performance Studies: The document describes performance studies conducted to evaluate the analytical characteristics of the assay, calibrators, and controls, which is typical for IVD devices to demonstrate their reliability and accuracy.
- Predicate Devices: The mention of predicate devices (K013359, K082488) which are also IVD assays and controls further supports that this device falls under the IVD category.
The information provided clearly indicates that this device is designed to be used outside of the body to analyze human specimens for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DFC, JIT, JJX
Device Description
The TQ Lp(a) Gen.2 test principle is a particle-enhanced immunturbidimetric 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
(1) The cobas c Tina-quant Lipoprotein (a) Gen.2 assay was evaluated for several performance characteristics, including precision, LoB, LoD, LoQ, high dose hook effect, cross reactivity, method comparison, interfering substances, anticoagulants, linearity, reagent on-board stability, and reagent shelf life stability.
(2) The Preciset Lp(a) calibrator set was evaluated for value assignment and stability.
(3) The PreciControl Lp(a) control set was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Lower Limits of Measure (TQ Lp(a) Gen.2 assay):
LoB: 3 mg/dL
LoD: 4 mg/dL
LoQ: 6 mg/dL
Hook Effect (TQ Lp(a) Gen.2 assay): No hook effect up to 190 mg/dL
Precision (TQ Lp(a) Gen.2 assay):
Repeatability = Within-run precision:
Control L: Mean 20.3 mg/dL, SD 0.3, CV 1.4%
Control H: Mean 61.5 mg/dL, SD 0.6, CV 1.0%
Pool 1: Mean 7.0 mg/dL, SD 0.4, CV 5.4%
Pool 2: Mean 16.1 mg/dL, SD 1.0, CV 6.2%
Pool 3: Mean 30.9 mg/dL, SD 0.7, CV 2.4%
Pool 4: Mean 79.4 mg/dL, SD 0.7, CV 0.9%
Intermediate Precision = Total precision/Between-run precision:
Control L: Mean 20.3 mg/dL, SD 0.3, CV 1.6%
Control H: Mean 61.5 mg/dL, SD 0.7, CV 1.1%
Pool 1: Mean 7.0 mg/dL, SD 0.5, CV 7.6%
Pool 2: Mean 16.1 mg/dL, SD 1.0, CV 6.4%
Pool 3: Mean 30.9 mg/dL, SD 0.9, CV 2.9%
Pool 4: Mean 79.4 mg/dL, SD 0.9, CV 1.1%
Interferences and cross reactivity (TQ Lp(a) Gen.2 assay):
Icterus (conjugated and unconjugated bilirubin): no significant interference up to an I index of 60 (approximately 60 mg/dL)
Hemolysis: no significant interference up to an H index of 1000 (approximately 1000 mg/dL)
Lipemia: no significant interference up to an L index of 2000
Plasminogen: no significant cross reactivity up to 150 mg/dL
Apolipoprotein B: no significant cross reactivity up to 200 mg/dL
Rheumatoid Factor: no significant interference up to 1200 IU/mL
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 submits | |
| official notification as required by Section 510(k) of the Federal Food, Drug | ||
| and Cosmetics Act of our intention to market the device described in this | ||
| Premarket Notification [510(k)]. | ||
| The purpose of this premarket notification is to obtain FDA review and | ||
| clearance for the cobas c Tina-quant Lipoprotein (a) Gen.2 assay, Preciset | ||
| Lp(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 and | ||
| unassayed) | ||
| Establishment | ||
| registration | For the cobas c Tina-quant Lipoprotein (a) Gen.2 assay, Preciset Lp(a) Gen.2 | |
| calibrator set, and PreciControl Lp(a) Gen.2 control set, the establishment | ||
| registration number for Roche Diagnostics GmbH in Mannheim, Germany is |
- The establishment registration number for Roche Diagnostics
United States is 1823260. | |
Continued on next page
.
.
.
1
| Classification | The FDA has classified the Low-Density Lipoprotein Immunological Test
System (TQ Lp(a) Gen.2) and the calibrator (Preciset Lp(a)) as Class II
devices.
The FDA has classified the single (specified) analyte controls (assayed and
unassayed) (PreciControl Lp(a)) as a Class 1 (reserved) device. | | | | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------------|------------------------|--|--|
| | Panel | Product
Code | Classification Name | Regulation | | |
| | Clinical
Chemistry | DFC | Low-Density Lipoprotein
Immunological Test System | 21 CFR
866.5600 | | |
| | Clinical
Chemistry | الا | Calibrator, secondary | 21 CFR
862.1150 | | |
| | Clinical
Chemistry | الا ال | Single (specified) analyte controls
(assayed and unassayed) | 21 CFR
862.1660 | | |
| | | | | | | |
| Performance
standards | To date, no performance standards that affect this device have been finalized
under Section 514 of the Act.
Draft labeling sufficient to describe the device, its intended use, and the
directions for use on the cobas c 501 analyzer is attached. We believe the
draft version of the device labeling presented in Section 8 contains all of the
technical information required per 21 CFR 809.10 for the cobas c Tina-quant
Lipoprotein (a) Gen.2 test system. | | | | | |
| Proposed
labeling | | | | | | |
| | | | | Continued on next page | | |
. .
·
2
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
Page 3 of 10
3
.
| Substantial
equivalence | The cobas c Tina-quant Lipoprotein (a) Gen.2 Test System is substantially
equivalent 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 Diazyme
Lp(a) control set, General Atomics (K082488). |
| Substantial
equivalence -
comparison | The following tables compare the cobas c Tina-quant Lipoprotein (a) Gen.2
assay, Preciset Lp(a) Gen.2 calibrator set, and PreciControl Lp(a) Gen.2
control set with their respective predicate devices. |
| | Continued on next page |
.
.
Page 4 of 10
.
. .
. . . . . .
4
.
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) | |
| Intended | ||
| Use/Indications | ||
| for Use | The Lp(a)-Latex Seiken Assay | |
| kit is an in vitro diagnostic test | ||
| for the quantitative | ||
| determination of lipoprotein(a) | ||
| [Lp(a)] in huma serum and | ||
| plasma samples using Hitachi | ||
| 917 analyzer. The measurement | ||
| of Lp(a) is useful in evaluating | ||
| lipid metabolism disorders and | ||
| assessing atherosclerotic | ||
| cardiovascular disease in specific | ||
| populations, when used in | ||
| conjunction with clinical | ||
| evaluation and other lipoprotein | ||
| tests. | 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 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. | ||
| 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 | ||
| Instrument | ||
| Platform | Roche/Hitachi 917 analzyer | cobas c 501 analyzer |
| Calibrator | Lp(a)-Latex Seiken Assay Kit | |
| Calibrators | Preciset Lp(a) Gen.2 calibrator | |
| set | ||
| Calibration | ||
| Frequency | After reagent lot change and as | |
| required following quality | ||
| control procedures. | same | |
| Calibration | ||
| mode | Six point; spline | same |
| Controls | commercially available controls | PreciControl Lp(a) control set |
| (2 levels) | ||
| Reagent active | ||
| ingredients | R1: glycine buffer solution |
R2: latex particles with anti- | R1: glycine buffer solution
R3: latex particles with anti- |
5
| Comparison of
assays –
similarities and
differences
| (continued) | Assay Comparison | ||
|---|---|---|---|
| Feature | Lp(a)-Latex Seiken assay | ||
| (predicate device: K013359) | TQ Lp(a) Gen.2 assay | ||
| (candidate device) | |||
| Reagent | |||
| Stability | 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 | |||
| Measuring | |||
| range | 2.0 – 80.0 mg/dL | 6.0 – 80.0 mg/dL | |
| Lower | |||
| Limits of | |||
| Measure | LDL: 2.0 mg/dL |
LoB, LoD, and LoQ not tested | LDL: not tested
LoB: 3 mg/dL
LoD: 4 mg/dL
LoQ: 6 mg/dL |
| | Hook Effect | Not tested | No hook effect up to 190
mg/dL |
| | Expected
Values | cutoff point: 30 mg/dL
Reference ranges have not been
established for this assay for
different ethnic populations or
disease states. Since Lp(a)
levels are largely influenced by
hereditary factors and vary with
ethnic populations, it is
recommended that each
laboratory establish its own
expected values. | same |
6
| Comparison of
assays -
similarities and
differences
| (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% |
7
| Feature | Lp(a)-Latex Seiken assay
(predicate device: K013359) | TQ Lp(a) Gen.2 assay
(candidate device) |
|------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Interferences
and cross
reactivity | Icterus (conjugated and
unconjugated bilirubin):
no significant interference up
to 30 mg/dL | Icterus (conjugated and
unconjugated bilirubin):
no significant interference up
to an I index of 60
(approximately 60 mg/dL) |
| | Hemolysis:
no significant interference up
to 500 mg/dL | Hemolysis:
no significant interference up
to an H index of 1000
(approximately 1000 mg/dL) |
| | Triglycerides:
no significant interference up
to 1500 mg/dL | Lipemia:
no significant interference up
to an L index of 2000 |
| | Plasminogen:
no significant interference up
to 200 mg/dL | Plasminogen:
no significant cross
reactivity up to 150 mg/dL |
| | Apolipoprotein B:
no significant interference up
to 200 mg/dL | Apolipoprotein B:
no significant cross
reactivity up to 200 mg/dL |
| | | Rheumatoid Factor:
no significant interference up
to 1200 IU/mL |
| | | Drugs:
No interference was found at
therapeutic concentrations
using common drug panels |
Continued on next page
·
8
Comparison of calibrators – similarities and differences
| Calibrator Comparison | ||
|---|---|---|
| Feature | Diazyme Lp(a) calibrator | |
| (predicate device: K082488) | Preciset Lp(a) Gen.2 | |
| calibrator set | ||
| (candidate device) | ||
| Intended | ||
| use | The Diazyme Lp(a) | |
| calibrator set is intended for | ||
| use in establishing the | ||
| calibration curve for the | ||
| Diazyme Lp(a) reagents by | ||
| turbidimetry. | 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. | ||
| Analyte | Lipoprotein (a) | same |
| Format & | ||
| matrix | Consists of 5 lyophilized | |
| human serum calibrators | Consists of 5 lyophilized | |
| human 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.2 | |
| control set | ||
| (candidate device) | ||
| Intended | ||
| use | The Diazyme control set is | |
| intended for use in | ||
| monitoring the quality | ||
| control of results obtained | ||
| with the Diazyme Lp(a) | ||
| reagents by turbidimetry. | 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. | ||
| Analyte | Lipoprotein (a) | same |
| Format & | ||
| matrix | Consists of 2 lyophilized | |
| human serum controls | Consists of 2 lyophilized | |
| human plasma controls | ||
| Storage | 2-8°C | same |
9
| Evaluations
summary | (1) The cobas c Tina-quant Lipoprotein (a) Gen.2 assay was evaluated for
several performance characteristics, including precision, LoB, LoD,
LoQ, high dose hook effect, cross reactivity, method comparison,
interfering substances, anticoagulants, linearity, reagent on-board
stability, and reagent shelf life stability. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (2) The Preciset Lp(a) calibrator set was evaluated for value assignment
and stability. |
| | (3) The PreciControl Lp(a) control set was evaluated for value assignment
and stability. |
| | A summary of the evaluation studies is provided in Section 5-Analytical
Performance Characteristics. |
| Confidentiality | Roche Diagnostics requests that the FDA not disclose the nature or existence
of the premarket notification until the substantial equivalence decision has
been 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 not
hesitate to contact this office. |
| | Lisa K. Klinedinst
Roche Diagnostics
Regulatory Affairs Consultant
Phone: 317-521-1942
Fax: 317-521-2324 |
| | Date prepared: November 28, 2012 |
10
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
11
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
12
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)