(52 days)
Not Found
No
The device description details a standard immunoturbidimetric assay for measuring apolipoprotein B, which relies on chemical reactions and optical measurements, not AI/ML algorithms. There are no mentions of AI, DNN, or ML in the provided text, and the performance studies focus on traditional analytical metrics like precision and method comparison.
No
The device is an in vitro diagnostic (IVD) test for measuring apolipoprotein B, used in the diagnosis and treatment of lipid disorders, not for directly treating a condition.
Yes
The device is described as an "Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma" and states that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis," indicating its role in diagnosis.
No
The device description clearly indicates a physical assay kit involving antibodies and turbidimetric measurement, which are hardware components and chemical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma". The phrase "in vitro" is a key indicator of an IVD. It also mentions the use of the measurements "in the diagnosis and treatment of lipid disorders and atherosclerosis," which is a diagnostic purpose.
- Device Description: The description details how the device works by reacting with a sample (serum or plasma) outside of the body ("in vitro") to measure a substance (apolipoprotein B).
- Predicate Device: The mention of a predicate device (K860894; Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay) which is also an assay for measuring substances in samples, further supports its classification as an IVD.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma on automated clinical chemistry analyzers.
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.
Product codes
DFC
Device Description
A device for the measurement of human apolipoprotein B in serum or plasma. Anti-apolipoprotein B antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically.
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)
The performance characteristics of the Tina-quant Apolipoprotein B ver.2 Assay and the predicate device are compared in the table below.
Precision:
Tina-quant Apolipoprotein B ver.2:
- Within run CV: 1.5% @ 29 mg/dL (serum), 0.5% @ 112 mg/dL (serum), 0.8% @ 69 mg/dL (control), 0.5% @ 152 mg/dL (control)
- Between Day CV: 2.5% @ 26 mg/dL (serum), 1.1% @ 127 mg/dL (serum), 1.0% @ 80 mg/dL (control), 1.9% @ 155 mg/dL (control)
Apolipoprotein B (predicate):
- Inter-assay Precision: 1.9% CV @ 1.04 g/L
- Intra-assay Precision: 2.4% CV @ 1.08 g/L
Method Comparison:
Tina-quant Apolipoprotein B ver.2 (Y) / Nephelometric method (X) (Bablok/Passing):
y = 1.127 - 2.849 mg/dL
r = 0.884
Dade Behring N Antisera Apo B (Y) / radioimmunodiffusion commercial method (X):
y(BN)= 0.94(RID) - 0.004 g/L
r= 0.99
Hook Effect:
No effect up to 600 mg/dL for Tina-quant Apolipoprotein B ver.2. NA for predicate.
Analytical sensitivity (LDL):
Tina-quant Apolipoprotein B ver.2: 1.5 mg/dL
Apolipoprotein B (predicate): Established by the lower limit of the reference curve and depends therefore upon the concentration of the proteins in the N Apolipoprotein Standard Serum.
Limitations:
Tina-quant Apolipoprotein B ver.2:
- Icterus: No significant interference up to an I index of 60 mg/dL (conjugated and unconjugated).
- Hemolysis: No significant interference up to an H index of 1000.
- Lipemia: No significant interference up to an L index of 1000.
- Anti-human apolipoprotein B antibodies from sheep show no cross-reactivity with apolipoprotein A-I or A-II.
Apolipoprotein B (predicate):
- Turbidity and particles in the sample can interfere with the test. Therefore particulates resulting from incompleted coagulation or denaturation of proteins should be removed prior to assay by centrifugation.
- In isolated cases excessive concentrations of triglycerides or hyperlipemic samples may disturb the Apo B assay. In such cases the effect of the disturbance can be reduced by retesting the sample in a higher dilution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics provided are precision (CV), method comparison (correlation coefficient 'r', linear regression equations), analytical sensitivity (LDL), and hook effect. Specific sensitivity, specificity, PPV, or NPV values are not explicitly stated.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| NOV | 1 6 2001 |
|---|---|
| ----- | ---------- |
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics 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 | A device for the measurement of human apolipoprotein B in serum or plasma. Anti-apolipoprotein B antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically. |
| Intended use | Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma on automated clinical chemistry analyzers. |
| Indications for Use | 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. |
:
1
Substantial Equivalence
The Tina-quant Apolipoprotein B ver.2 is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay (K860894).
Substantial equivalence similarities
The following table compares the Tina-quant Apolipoprotein B ver.2 Assay with the predicate device.
| Feature | Tina-quant
Apolipoprotein B ver.2 | Apolipoprotein B (predicate) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidmetric assay
for the in vitro quantitative
determination of
apolipoprotein B in human
serum and plasma on
automated clinical
chemistry analyzers. | In vitro diagnostic reagent for
the quantitative determination
of apolipoprotein B in human
serum with the Behring
nephelometers. |
| Indication 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. | 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. |
| Assay Protocol | Immunoturbidometric | Immunoturbidometric |
| Traceability /
Standardization | Standardized with regard to
the IFCC reference
preparation SP3-07. | Not provided in insert |
| Calibration
Interval | • After each lot
• as required by QC
procedures | • After each lot
• as required by QC
procedures |
2
510(k) Summary, Continued
Substantial equivalence differences
The following table compares the Tina-quant Apolipoprotein B ver.2 Assay with the predicate device.
| Feature | Tina-quant Apolipoprotein
B ver.2 | Apolipoprotein B
(predicate) |
|----------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | Serum and plasma (heparin,
EDTA) | Serum |
| Reagent
Stability | Store at 2-8°C,
unopened.42 days opened and
refrigerated on analyzer. | Store at 2-8°C,
unopened.Use within 4 weeks, if
directly after use if vials
are stopped, capped and
stored at 2-8°C.Do not use remaining
antiserum if left open on
nephelometer for longer
than 5 days at 8 hours
daily or comparable
period of time.Do not freeze. |
| Calibrator | C.f.a.s. Lipids | N Apoliporprotein Standard
Serum (human) |
| Controls | Precinorm L, Precipath L | Apolipoprotein Control
Serum CHD (human) |
| Expected
Values | Females: 60 - 117 mg/dL
Males: 66 - 133 mg/dL | Females: 0.66 - 1.25 g/L
Males: 0.65 - 1.40 g/L |
| Instrument | Roche/Hitachi Clinical
Chemistry Analyzers | Dade Behring
Nephelometers |
| Measuring
Range | 20 - 400 mg/dL | Not provided in insert |
3
510(k) Summary, Continued
Substantial equivalence performance characteristics 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 Apolipoprotein
B ver.2 | Apolipoprotein B
(predicate) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within run CV | Inter-assay Precision |
| | 1.5% @ 29 mg/dL (serum) | 1.9% CV @ 1.04 g/L |
| | 0.5% @ 112 mg/dL (serum) | Intra-assay Precision |
| | 0.8% @ 69 mg/dL (control) | |
| | 0.5% @ 152 mg/dL (control) | 2.4% CV @ 1.08 g/L |
| | Between Day CV | |
| | 2.5% @ 26 mg/dL (serum) | |
| | 1.1% @ 127 mg/dL (serum) | |
| | 1.0% @ 80 mg/dL (control) | |
| | 1.9% @ 155 mg/dL (control) | |
| Method
Comparison | Bablok/Passing:
Tina-quant Apolipoprotein B
ver.2 (Y) / Nephelometric
method (X).
$y = 1.127 - 2.849$ mg/dL
$r = 0.884$ | Dade Behring N Antisera
Apo B (Y) /
radioimmunodiffusion
commerical method (X):
$y(BN)= 0.94(RID) - 0.004$ g/L
$r= 0.99$ |
| Hook Effect | No effect up to 600 mg/dL | NA |
| Analytical
sensitivity (LDL) | 1.5 mg/dL | Established by the lower
limit of the reference
curve and depends
therefore upon the
concentration of the
proteins in the N
Apolipoprotein Standard
Serum |
4
510(k) Summary, 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 Apolipoprotein
B ver.2 | Apolipoprotein B |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | Icterus: No significant interference up to an I index of 60 mg/dL (conjugated and unconjugated) Hemolysis: No significant interference up to an H index of 1000. Lipemia: No significant interference up to an L index of 1000. Anti-human apolipoprotein B antibodies from sheep show no cross-reactivity with apolipoprotein A-I or A-II. | Turbidity and particles in the sample can interfere with the test. Therefore particulates resulting from incompleted coagulation or denaturation of proteins should be removed prior to assay by centrifugation. In isolated cases excessive concentrations of triglycerides or hyperlipemic samples may disturb the Apo B assay. In such cases the effect of the disturbance can be reduced by retesting the sample in a higher dilution. |
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kay A. Taylor Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K013206
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
NOV 1 6 2001
Dear Ms. Taylor:
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 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); good manufacturing practice requirements as set 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.
6
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 predicate 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/cdrh/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
7
Indications for Use Statement NOV 1 6 2001
K013206 510(k) Number (if known): N/A
Device Name: Tina-quant Apolipoprotein B ver.2
Indications For Use:
Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma on automated clinical chemistry analyzers.
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.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013206