(54 days)
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No
The summary describes a standard in vitro diagnostic reagent system based on immunological agglutination and turbidimetric measurement. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic reagent system designed to measure transferrin levels in human serum and plasma to aid in the diagnosis of certain conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma" and that "Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia." This clearly indicates its role in aiding medical diagnosis.
No
The device is an in vitro diagnostic reagent system, which is a chemical/biological product used in conjunction with a hardware system (COBAS Integra) to perform a test. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma."
This statement clearly identifies the device as an in vitro diagnostic reagent system used to perform tests on biological samples (serum and plasma) outside of the body to aid in diagnosis.
N/A
Intended Use / Indications for Use
The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Product codes (comma separated list FDA assigned to the subject device)
DDG
Device Description
The Tina-quant Transferrin ver.2 Assay is based on the principle of immunological agglutination. Human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
Mentions image processing
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document compares the performance characteristics of the Tina-quant Transferrin ver.2 Assay with its predicate device. This includes:
- Intra-assay precision (% CV): 0.86% at 1.35 g/L and 0.77% at 3.36 g/L.
- Between Day Precision (% CV): 1.8% at 1.32 g/L and 1.9% at 3.70 g/L.
- Limitations concerning interference from Icterus, Hemolysis, Lipemia (up to 500 mg/dL Intralipid), Rheumatoid factors, and Gammopathy type IgM (Waldenstroem) sera. For the latter, the device has a "High Activity" check and allows for post-dilution to obtain correct results.
- Analytical sensitivity (LDL): 0.013 g/L.
- Method comparison: Tina-quant Transferrin ver.2 (Y) / COBAS Integra Transferrin (X) with y = 1.06x + 0.03 and r = 0.996.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Intra-assay precision (% CV): 0.86% at 1.35 g/L, 0.77% at 3.36 g/L
- Between Day Precision (% CV): 1.8% at 1.32 g/L, 1.9% at 3.70 g/L
- Analytical sensitivity (LDL): 0.013 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
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).
0
11 1
1
| 510(k) Summary | K012393 |
|---|---|
| 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 - 3831 |
Contact Person: Sherri L. Coenen
Date Prepared: July 25, 2001 |
| Device Name | Proprietary name: Tina-quant Transferrin ver.2
Common name: Transferrin
Classification name: Transferrin immunological test system |
| Device Description | The Tina-quant Transferrin ver.2 Assay is based on the principle of immunological agglutination. Human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm. |
| Intended use | The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum. |
| Indications for Use | A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. |
.
1
510(k) Summary, Continued
Substantial Equivalence The Tina-quant Transferrin ver.2 is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the COBAS Integra Tina-quant Transferrin (K951595).
Substantial equivalence similarities
The following table compares the Tina-quant Transferrin ver.2 Assay with the predicate device.
| Feature | Tina-quant Transferrin
ver.2 | Transferrin |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassette COBAS
Integra Tina-quant
Trasferrin ver.2 (TRSF2)
contains an in vitro
diagnostic reagent system
intended for use on
COBAS Integra systems
for the quantitative
immunological
determination of human
transferrin in serum. | The cassette COBAS
Integra Transferrin
(TRSF) contains an in
vitro diagnostic reagent
system intended for use
on COBAS Integra
systems for the
quantitative
immunological
determination of human
transferrin in serum. |
| Indication for Use | A transferrin
immunological test system
is a device that consists of
the reagents used to
measure by
immunological
techniques the transferrin
(an iron-binding and
transporting serum protein)
in serum and plasma.
Measurement of
transferrin levels aids in
the diagnosis of
malnutrition,acute
inflammation, infection,
and red blood cell
disorders,such as iron
deficiency anemia. | A transferrin
immunological test
system is a device that
consists of the reagents
used to measure by
immunochemical
techniques the
transferrin (an iron-
binding and
transporting serum
protein) in serum,
plasma, and other body
fluids. Measurement of
transferrin levels aids in
the diagnosis of
malnutrition, acute
inflammation, infection,
and red blood cell
disorders, such as iron
deficiency anemia. |
2
510(k) Summary, Continued
Substantial equivalence similarities
The following table compares the Tina-quant Transferrin ver.2 Assay with the predicate device.
| Feature | Tina-quant Transferrin
ver.2 | Transferrin |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Protocol | Immunoturbidimetric
assay | Immunoturbidimetric
assay |
| Instrument | COBAS Integra Clinical
Chemistry Analyzers | COBAS Integra
Clinical Chemistry
Analyzers |
| Traceability /
Standardization | Standardized against the
reference preparation
CRM 470, corresponding
to RPPHS (Reference
Preparation Protein in
Human Serum) | Standardized against
the reference
preparation CRM 470,
corresponding to
RPPHS (Reference
Preparation Protein in
Human Serum) |
Substantial equivalence differences
The following table compares the Tina-quant Transferrin ver.2 Assay with the predicate device.
| Feature | Tina-quant
Transferrin ver.2 | Transferrin |
|-----------------|---------------------------------|-----------------|
| Sample Type | Human serum and
plasma | Human serum |
| Measuring Range | 1.3 - 520 mg/dL | 80 – 1280 mg/dL |
3
Substantial equivalence – performance characteristics, cont.
The performance characteristics of the Tina-quant Transferrin ver.2 Assay and the predicate device are compared in the table below. .
| Feature | Tina-quant Transferrin
ver.2 | Transferrin |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intra-assay
precision (% CV) | 0.86% at 1.35 g/L
0.77% at 3.36 g/L | 1.5% at 1.10 g/L
0.83% at 3.32 g/L |
| Between Day
Precision (% CV) | 1.8% at 1.32 g/L
1.9% at 3.70 g/L | 1.6% at 1.10 g/L
0.97% at 3.32 g/L |
| Limitations | Icterus: No significant interference Hemolysis: No significant interference Lipemia: No significant interference up to an Intralipid level of 500 mg/dL Rheumatoid factors: No significant interference Interference of Gammopathy type IgM (Waldenstroem) sera is recognized by the “High Activity” check. In case samples are flagged “High Act”, correct results can be obtained after post-dilution. | Icterus: No significant interference Hemolysis: No significant Lipemia: No significant interference Rheumatoid factors: No significant interference |
| Analytical
sensitivity (LDL) | 0.013 g/L | 0.58 g/L |
| Method
comparison | Tina-quant Transferrin ver.2 (Y) / COBAS Integra Transferrin (X)
$y = 1.06x + 0.03$ $r = 0.996$ | Transferrin (Y) / nephelometric determination (X)
$y = 1.06x + 0.01 g/L$ $r = 0.958$ |
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100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
and the comments of the country of
:
:
Substantial equivalence performance characteristics, cont.
.
:
:
:
. ·
:
:
.
:
The performance characteristics of the Tina-quant Transferrin The porcennance the predicate device are compared in the table below.
.
11:11:1
.
| Feature | Tina-quant Transferrin
ver.2 | Transferrin |
|--------------------------|---------------------------------|---------------------------------|
| Calibration
frequency | • after reagent lot change | • after reagent lot change |
| Expected values | 2.0 – 3.6 g/l (200 – 360 mg/dl) | 2.0 – 3.6 g/l (200 – 360 mg/dl) |
:
:
:
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
SEP 1 9 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
K012393 Re:
Trade Name: Roche Diagnostics Tina-quant® Transferrin ver.2 Regulatory Class: 21 CFR § 866.5880 Regulatory Class: II Product Code: DDG Dated: July 25, 2001 Received: July 27, 2001
Dear Ms. Coenen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 nouticate 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 If you desire specific darices), please contact the Office of Compliance at additionally 607.10 for in This angliestions on the promotion and advertising of your device, (201) 59 rttact 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 mormation on your responsibility on sumer Assistance at its toll-free number (800) 638-2041 or 1101) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
Roche Diagnostics Corp.
510(k) Number (if known): K012393
Device Name: Tina-quant Transferrin ver.2
Indications For Use:
The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Soumen S. Altare
Ivision Sian-Off Division of Clinical Laboratory Devices
510(k) Number K012393