(49 days)
Not Found
No
The description details a turbidimetric assay for quantitative determination of apolipoprotein B, which is a standard laboratory method and does not involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic reagent system used for quantitative immunological determination of human apolipoprotein B, which aids in the diagnosis and treatment of lipid disorders, rather than directly treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "quantitative immunological determination of human apolipoprotein B ... Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis." This indicates its role in determining a medical condition.
No
The device is an in vitro diagnostic reagent system, which is a physical product used in laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "In vitro diagnostic reagent system".
- Measurement: It is designed to measure a substance (human apolipoprotein B) in biological samples (serum and plasma).
- Purpose: The measurements are used in the "diagnosis and treatment of lipid disorders and atherosclerosis," which is a diagnostic purpose.
- Device Description: The description details a method for determining the substance in vitro (outside the body).
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein B in serum and plasma.
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 (comma separated list FDA assigned to the subject device)
DFC
Device Description
Human apolipoprotein B forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
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 are compared with the predicate device in the tables provided for Precision, Method Comparison, Prozone Effect, Analytical sensitivity (LDL), and Limitations.
Precision:
Tina-quant Apolipoprotein B ver.2:
Within run CV: 1.2% @ 0.8 g/L; 1.1% @ 1.5 g/L
Between Day CV: 2.9% @ 0.8 g/L; 3.2% @ 1.5 g/L
Method Comparison:
Bablok/Passing: Tina-quant Apolipoprotein B ver.2 (Y) / COBAS Integra Apolipoprotein B (X).
y = 1.02x + 0.03 g/L
r = 0.954
Prozone Effect:
No effect up to 6 g/L
Analytical sensitivity (LDL):
0.046 g/L
Limitations:
Icterus: No significant interference
Hemolysis: No significant interference
Lipemia: No significant interference up to an Intralipid level of 1000 mg/dL
Rheumatoid factors: No significant interference
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Within run CV: 1.2% @ 0.8 g/L; 1.1% @ 1.5 g/L
Between Day CV: 2.9% @ 0.8 g/L; 3.2% @ 1.5 g/L
Analytical sensitivity (LDL):
0.046 g/L
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
NOV 1 3 2001
: :
| 510(k) Summary | K013207 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 (317) 521 - 3544 |
| Contact Person: Kay A. Taylor | |
| Date Prepared: September 24, 2001 | |
| Device Name | Proprietary name: Tina-quant Apolipoprotein ver.2 |
| Common name: Apolipoprotein B | |
| Classification name: Low-density lipoprotein immunological test system | |
| Device Description | Human apolipoprotein B forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm. |
| Intended use | In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein B in serum and plasma. |
| Indications for Use | For the quantitative determination of apolipoprotein B in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis. |
:
1
510(k) Summary, Continued
The Tina-quant Apolipoprotein B ver.2 is substantially equivalent to other Substantial devices legally marketed in the United States. We claim equivalence to the Equivalence COBAS Integra Tina-quant Apolipoprotein B (K990595).
Substantial equivalence similarities
The following table compares the Tina-quant Apolipoprotein B ver.2 Assay with the predicate device.
| Feature | Tina-quant
Apolipoprotein B ver.2 | Apolipoprotein B
(predicate) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro diagnostic reagent
system intended for use on
COBAS INTEGRA system
for the quantitative
immunological
determination of human
apolipoprotein B in serum
and plasma. | In vitro diagnostic reagent
system intended for use on
COBAS Integra (analyzer
model) for the quantitative
immunological determination
of human apolipoprotein B in
serum and plasma. |
| 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 |
| Instrument | COBAS Integra Clinical
Chemistry Analyzers | COBAS Integra Clinical
Chemistry Analyzers |
| Traceability /
Standardization | Standardized with regard to
the IFCC reference
preparation SP3-07. | Standardized with regard to
the IFCC reference
preparation SP3-07. |
| Sample Type | Serum and plasma | Serum and plasma |
2
510(k) Summary, Continued
| Feature | Tina-quant Apolipoprotein
B ver.2 | Apolipoprotein B
(predicate) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibration
Interval | After each lot | After each lot |
| Formulation | R: TRIS buffer,
polyethylene glycol,
detergent, preservative
(liquid).
SR: Anti-apolipoprotein B
antibody (sheep) specific for
human Apo B, TRIS buffer,
preservative (liquid). | R: Anti-apolipoprotein B T
antiserum (rabbit) specific for
human Apo B, in phosphate
buffer stabilized with 0.09%
sodium azide in vial A
(liquid). |
Substantial equivalence —
differences
The following table compares the Tina-quant Apolipoprotein B ver.2 Assay with the predicate device.
| Feature | Tina-quant Apolipoprotein
B ver.2 | Apolipoprotein B
(predicate) |
|----------------------|----------------------------------------------------|----------------------------------------------------|
| Reagent
Stability | On board: 4 weeks | On-board: 12 weeks |
| Calibrator | C.f.a.s. Lipids | Apolipoprotein T Standard |
| Controls | Precinorm L, Precipath L | Apolipoprotein T Control |
| Expected
Values | Females: 0.60 - 1.17 g/L
Males: 0.66 - 1.33 g/L | Females: 0.50 - 1.30 g/L
Males: 0.60 - 1.40 g/L |
| Measuring
Range | 0.20 - 4.0 g/L
(0.10 - 4.0 g/L with rerun) | 0.26 - 3.9 g/L
(0.09 - 7.8 g/L with rerun) |
3
510(k) Summary, Continued
Substantial equivalence performance characteristics The performance characteristics of the Tina-quant Apolipoprotein B ver.2 The performance dicate device are compared in the table below.
| Feature | Tina-quant Apolipoprotein B ver.2 | Apolipoprotein B (predicate) |
|---|---|---|
| Precision | Within run CV | |
| 1.2% @ 0.8 g/L | ||
| 1.1% @ 1.5 g/L | ||
| Between Day CV | ||
| 2.9% @ 0.8 g/L | ||
| 3.2% @ 1.5 g/L | Within run CV | |
| 0.66% @ 1.30 g/L | ||
| 0.50% @ 2.22 g/L | ||
| Total CV | ||
| 2.1% @ 1.30 g/L | ||
| 0.98% @ 2.22 g/L | ||
| Method Comparison | Bablok/Passing: | |
| Tina-quant Apolipoprotein B ver.2 (Y) / COBAS Integra Apolipoprotein B (X). | ||
| y = 1.02x + 0.03 g/L | ||
| r = 0.954 | Bablok/Passing: | |
| Apolipoprotein B (Y)/ commercially available system (X). | ||
| y = 1.06x + 0.10 g/L | ||
| r = 0.983 | ||
| Prozone Effect | No effect up to 6 g/L | No effect up to 19.8 g/L |
| Analytical sensitivity (LDL) | 0.046 g/L | Determined by the lower limit of the standard curve which varies with the Apo B concentration of the calibrator. Typical concentration approximately 0.26 g/L |
4
Premarket Notification, 510(k) for Tina-quant Apolipoprotein B ver. 2 Test System on COBAS Integra Clinical Chemistry Analyzers, continued
Substantial equivalence performance characteristics, cont.
The performance characteristics of the Tina-quant Apolipoprotein B ver.2 Assay and the predicate device are compared in the table below.
| Feature | Tina-quant Apolipoprotein
B ver.2 | Apolipoprotein B |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | • Icterus: No significant
interference
• Hemolysis: No
significant interference
• Lipemia: No significant
interference up to an
Intralipid level of 1000
mg/dL
• Rheumatoid factors: No
significant interference | • Icterus: No significant
interference
• Hemolysis: No
significant
interference
• Lipemia: No
significant
interference
• Rheumatoid factors:
Levels of rheumatoid
factors higher than
300 IU/ml increase
the apparent
apolipoprotein B
concentration slightly. |
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 2001
Ms. Kay A. Taylor Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K013207 Re:
Trade/Device Name: Tina-quant Apolipoprotein B ver.2 Regulation Number: 21 CFR 866.5600 Regulation Name: Low density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC Dated: September 24, 2001 Received: September 25, 2001
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use Stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce provided to May 20, 1978, as condance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmette Act (rear the device, subject to the general controls provisions of the Act. The T ou may, therefore, mains of the Act include requirements for annual registration, listing of general controll pro resuring practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined (600 a00 rols. Existing major regulations affecting your device can may be subject to success reculations, Title 21, Parts 800 to 898. In addition, FDA may or found in the Outsting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc ac now that i Dr over device complies with other requirements of the Act that I Dri has intass and regulations administered by other Federal agencies. You must of any I cacial stututes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I all 6077, laoomig (21 CFR Part 820); and if applicable, the electronic form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 noalicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
NOV 1 3 2001
Indications for Use Statement
K013207 510(k) Number (if known): N/A
Device Name: Tina-quant Apolipoprotein B ver.2
Indications For Use:
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the In vitro diagnostic rougent by ecommination of human apolipoprotein B in serum and plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and A npoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
e un Cooper
. vices ion of Clinical Lal 510(k) Number