Predicate Devices

Tina-quant Transferrin

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a standard immunoturbidimetric assay and do not mention any AI or ML components.

Therapeutic

No
The device is an in vitro diagnostic assay used for measuring transferrin levels to aid in diagnosis, not to treat or directly manage a disease.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia," which indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "Immunoturbidometric assay" based on "immunological agglutination" and "reagents" used to measure transferrin. This indicates a chemical/biological assay, not a software-only device.

IVD (In Vitro Diagnostic)

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 "Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma". The term "in vitro" is a key indicator of an IVD.
Purpose: The purpose is to measure a substance (transferrin) in a sample (serum and plasma) taken from the human body to aid in diagnosis. This is the fundamental definition of an IVD.
Device Description: The description details a laboratory test method (immunological agglutination measured turbidimetrically) performed on biological samples.
Performance Studies: The performance studies focus on analytical characteristics relevant to laboratory testing (precision, sensitivity, interference, method comparison).

All these elements align with the characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. 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. Anti-transferrin antibodies react with the antigen in the sample to form an antigen/antibody complex. Following agglutination, this is measured turbidimetrically. Addition of PEG allows the reaction to progress rapidly to the end point and increases sensitivity.

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 Transferrin ver.2 Assay and the predicate device (Tina-quant Transferrin) are compared.
Key results include precision and method comparison:
Intra-assay precision (% CV) for Human sera: 1.0% at 1.36 g/l (136 mg/dl), 2.7% at 3.59 g/l (359 mg/dl). For Controls: 2.1% at 2.90 g/l (290 mg/dl), 1.0% at 4.31 g/l (431 mg/dl).
Between Day Precision (% CV) for Human sera: 0.0% at 1.60 g/l (160 mg/dl), 1.4% at 3.38 g/l (338 mg/dl). For Controls: 1.7% at 2.88 g/l (288 mg/dl), 1.4% at 4.35 g/l (435 mg/dl).
Limitations:
Icterus: No significant interference with up to an I index of 60
Hemolysis: No significant interference up to an H index of 1000
Lipemia (Intralipid): No significant interference up to an L index of 500
Rheumatoid factors

Regulation Number and Section

§ 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).

Summary

0

510(k) Summary

SEP 1 9 2001

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics Corporation name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 576 - 3544 Contact Person: Sherri L. Coenen Date Prepared: July 26, 2001 Device Name Proprietary name: Tina-quant Transferrin ver.2 Common name: Transferrin Classification name: Transferrin immunological test system The Tina-quant Transferrin ver.2 Assay is based on the principle of Device Description immunological agglutination. Anti-transferrin antibodies react with the antigen in the sample to form an antigen/antibody complex. Following agglutination, this is measured turbidimetrically. Addition of PEG allows the

reaction to progress rapidly to the end point and increases sensitivity.

1

Substantial equivalence similarities

:

: .

The following table compares the Tina-quant Transferrin ver.2 Assay with the predicate device.

| Feature | Tina-quant Transferrin
ver.2 | Tina-quant Transferrin |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidometric
assay for the in vitro
quantitative determination
of transferrin in human
serum and plasma on
automated clinical
chemistry analyzers. | Immunoturbidometric
assay for the in vitro
quantitative determination
of transferrin in human
serum and plasma on
automated clinical
chemistry analyzers. |
| 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. |
| Assay Protocol
Instrument | Immunoturbidimetric
Roche/Hitachi Clinical
Chemistry Analyzers | Immunoturbidimetric
Roche/Hitachi Clinical
Chemistry Analyzers |
| Sample Type | Human serum and plasma | Human serum and plasma |
| 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) |
| Feature | Tina-quant Transferrin ver.2 | Tina-quant Transferrin |
| Antibody source | rabbit | goat |
| Measuring Range | Roche/Hitachi 704/902
0.02 - 5.00 g/l
(1 - 500 mg/dl)
Maximum reportable range is dependent on the highest
standard concentration. | Roche/Hitachi 704/902
80 - 500 mg/dl
Maximum reportable range is
dependent on the highest
standard concentration. |
| | Roche/Hitachi 717/747
0.02 - 5.00 g/l
(1 - 500 mg/dl)
Extended measuring
range with rerun
0.02 - 7.50 g/l
(1 - 750 mg/dl)
Maximum reportable range
is dependent on the highest
standard concentration. | Roche/Hitachi
717/747/914
80 - 500 mg/dl
Extended measuring
range with rerun
80 - 1000 mg/dl
Maximum reportable range is
dependent on the highest
standard concentration. |
| | Roche/Hitachi
904/911/912/917/
Modular P
0.007 - 5.20 g/l
(0.7 - 520
mg/dl)
Extended measuring
range with rerun
0.007 - 7.80 g/l
(0.7 - 780
mg/dl)
Maximum reportable range
is dependent on the highest
standard concentration | Roche/Hitachi
904/911/912/917/
Modular P
15 - 500 mg/dl
Maximum reportable range is
dependent on the highest
standard concentration. |

2

Substantial equivalence differences

The following table compares the Tina-quant Transferrin ver.2 assay with the predicate device.

3

Substantial equivalence – performance characteristics

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 | Tina-quant Transferrin |
|------------------------------------|---------------------------------------------|----------------------------------|
| Intra-assay
precision (%
CV) | Human sera:
1.0% at 1.36 g/l (136 mg/dl) | Human sera:
0.8% at 169 mg/dl |
| | 2.7% at 3.59 g/l (359 mg/dl) | |
| | Controls:
2.1% at 2.90 g/l (290 mg/dl) | Controls:
0.8% at 217 mg/dl |
| | 1.0% at 4.31 g/l (431 mg/dl) | 0.8% at 403 mg/dl |
| Between Day
Precision (%
CV) | Human sera:
0.0% at 1.60 g/l (160 mg/dl) | Human sera:
3.0% at 169 mg/dl |
| | 1.4% at 3.38 g/l (338 mg/dl) | |
| | Controls:
1.7% at 2.88 g/l (288 mg/dl) | Controls:
1.4% at 217 mg/dl |
| | 1.4% at 4.35 g/l (435 mg/dl) | 1.5% at 403 mg/dl |

4

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 | Tina-quant Transferrin |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | Icterus: No significant interference with up to an I index of 60 Hemolysis: No significant interference up to an H index of 1000 Lipemia (Intralipid): No significant interference up to an L index of 500 Rheumatoid factors