(49 days)
No
The device description and performance studies focus on a standard immunoturbidimetric assay for quantitative determination of apolipoprotein A-1. There is no mention of AI, ML, image processing, or any data-driven algorithms beyond standard analytical calculations.
No
This device is an in vitro diagnostic (IVD) test used to measure a biomarker (apolipoprotein A-1) in patient samples. It is not intended to provide therapy or directly treat a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis."
No
The device description clearly states it is an "immunoturbidmetric assay" and involves "Anti-apolipoprotein A-1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically." This describes a chemical assay with physical components (reagents, samples) and a measurement method (turbidimetry), not a software-only device.
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 A-1 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 to measure a substance (apolipoprotein A-1). This is characteristic of an in vitro test.
- Sample Type: The device uses human serum and plasma, which are biological samples taken from the body for analysis outside the body.
- Testing Method: The method described (immunoturbidmetric assay) is a common laboratory technique performed on biological samples.
All these elements align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein A-1 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
DER
Device Description
A device for the measurement of human apolipoprotein A-1 in serum or plasma. Anti-apolipoprotein A-1 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)
Precision:
Within run CV
1.0% @ 40 mg/dL (serum)
0.6% @ 176 mg/dL (serum)
1.0% @ 157 mg/dL (control)
1.2% @ 83 mg/dL (control)
Between Day CV
2.4% @ 47 mg/dL (serum)
1.6% @ 179 mg/dL (serum)
1.2% @ 171 mg/dL (control)
2.4% @ 84 mg/dL (control)
Method Comparison:
Bablok/Passing: Tina-quant Apolipoprotein A-1 ver.2 (Y) / Nephelometric method (X).
y = 2.45+1.073 mg/dL
r = 0.781
Hook Effect:
No effect up to 600 mg/dL
Analytical sensitivity (LDL):
0.6 mg/dL
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 A-1 antibodies from sheep show no cross-reactivity with apolipoprotein B or A-II.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5580
Alpha -1-lipoprotein immunological test system.(a)
Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).(b)
Classification. Class II (performance standards).
0
NOV 1 6 2001
| 510(k) Summary | K.013249 |
|---|---|
| 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: Helen T. Torney
Date Prepared: September 25, 2001 |
| Device Name | Proprietary name: Tina-quant Apolipoprotein ver.2
Common name: Apolipoprotein A-1
Classification name: Alpha-1- lipoprotein immunological test system |
| Device Description | A device for the measurement of human apolipoprotein A-1 in serum or plasma. Anti-apolipoprotein A-1 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 A-1 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 The Tina-quant Apolipoprotein A-1 ver.2 is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Equivalence 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 A-1 ver.2 Assay with the predicate device.
| Feature | Tina-quant
Apolipoprotein A-1 ver.2 | Apolipoprotein A-1
(predicate) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidmetric assay
for the in vitro quantitative
determination of
apolipoprotein A-1 in
human serum and plasma
on automated clinical
chemistry analyzers. | In vitro diagnostic reagent for
the quantitative determination
of apolipoprotein A-1 in
human serum with the
Behring nephelometers. |
| Indication for
Use | For the quantitative
determination of
apolipoprotein A-1 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 A-1 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 SP1-01. | Not provided in insert |
| Calibration
Interval | • After each lot
• as required by QC
procedures | • After each lot
• as required by QC
procedures |
2
Substantial equivalence differences
The following table compares the Tina-quant Apolipoprotein A-1 ver.2 Assay with the predicate device.
| Feature | Tina-quant Apolipoprotein
A-1 ver.2 | Apolipoprotein A-1
(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: 108 - 225 mg/dL
Males: 104 - 202 mg/dL | Females: 1.25 - 2.15 g/L
Males: 1.10-2.05 g/L |
| Instrument | Roche/Hitachi Clinical
Chemistry Analyzers | Dade Behring
Nephelometers |
| Measuring
Range | 20 - 400 mg/dL | Not provided in insert |
3
Substantial equivalence performance characteristics The performance characteristics of the Tina-quant Apolipoprotein A-1 ver.2 Assay and the predicate device are compared in the table below.
| Feature | Tina-quant Apolipoprotein
A-1 ver.2 | Apolipoprotein A-1
(predicate) |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within run CV
1.0% @ 40 mg/dL (serum)
0.6% @ 176 mg/dL (serum)
1.0% @ 157 mg/dL (control)
1.2% @ 83 mg/dL (control)
Between Day CV
2.4% @ 47 mg/dL (serum)
1.6% @ 179 mg/dL (serum)
1.2% @ 171 mg/dL (control)
2.4% @ 84 mg/dL (control) | Inter-assay Precision
2.2% CV @ 1.58 g/L
Intra-assay Precision
5.7% CV @ 1.45 g/L |
| Method
Comparison | Bablok/Passing:
Tina-quant Apolipoprotein A-1
ver.2 (Y) / Nephelometric
method (X).
y = 2.45+1.073 mg/dL
r = 0.781 | Dade Behring N Antisera
Apo A-1 (Y) /
radioimmunodiffusion
commerical method (X):
y(BN)= 1.0 (RID) – 0.04
g/L
r= 0.98 |
| Hook Effect | No effect up to 600 mg/dL | NA |
| Analytical
sensitivity
(LDL) | 0.6 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
Substantial equivalence performance characteristics, cont.
The performance characteristics of the Tina-quant Apolipoprotein A-1 ver.2 Assay and the predicate device are compared in the table below.
| Feature | Tina-quant Apolipoprotein
A-1 ver.2 | Apolipoprotein A-1 |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 A-1 antibodies from sheep show no cross-reactivity with apolipoprotein B 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 Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Helen T. Torney Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
NOV 1 6 2001
Re: K013249
Trade/Device Name: Tina-quant Apolipoprotein A-1 ver.2 Regulation Number: 21 CFR 866.5580 Regulation Name: Alpha-1-lipoprotein immunological test system Regulatory Class: Class II Product Code: DER Dated: September 25, 2001 Received: September 28, 2001
Dear Ms. Torney:
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 (OS) 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, (1) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 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 Gutman
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
Ko13249 510(k) Number (if known): N/A
Device Name: Tina-quant Apolipoprotein A-1 ver.2
Indications For Use:
Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein A-1 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)
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number.
vision of Clinical Laboratory Devices
510(k) Number K013249