(92 days)
Not Found
No
The description focuses on immunochemical reactions and light scattering for quantitative measurement, with no mention of AI or ML.
No
The device is described as an in vitro diagnostic test for measuring substances in human body fluids to aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the TRF method "is an in vitro diagnostic test for the quantitative measurement of transferrin" and that "Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia." It also states that Protein 1 Calibrator is an "in vitro diagnostic product."
No
The device description clearly indicates it is an in vitro diagnostic test involving physical reagents (human serum based product, polygeline and rabbit plasma albumin based product) and relies on a physical system (Dimension Vista® System) to perform immunochemical reactions and light scattering measurements. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The TRF method is an in vitro diagnostic test...". It also describes the test's purpose: "quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine" and how these measurements "aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia." This clearly indicates the device is used to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The description details how the device works by analyzing human body fluids (serum, plasma, urine, CSF) using an immunochemical reaction to measure protein concentrations. This is a typical characteristic of an in vitro diagnostic device.
- Calibrators and Controls: The inclusion of "Protein 1 Calibrator" and "PROT3 CON" (quality control) are standard components of IVD systems used to ensure the accuracy and reliability of the test results.
- Predicate Devices: The mention of predicate devices with K numbers (K053075, K012470, K032237) indicates that this device is being compared to previously cleared IVD devices, further confirming its classification as an IVD.
All of these points strongly support the conclusion that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:
α₁-Acid Glycoprotein (A1AG)
α₁-Antitrypsin (A1AT)
β₂-Microglobulin (B2MIC)
C3 Complement (C3)
C4 Complement (C4)
Ceruloplasmin (CER)
Haptoglobin (HAPT)
Hemopexin (HPX)
Homocysteine (HCYS)
Immunoglobulin A (IGA)
Immunoglobulin E (IGE)
Immunoglobulin G (IGG) [serum/plasma] and (IGG-C) [cerebrospinal fluid]
Immunoglobulin G Subclass 1 (IGG1)
Immunoglobulin G Subclass 2 (IGG2)
Immunoglobulin G Subclass 3 (IGG3)
Immunoglobulin G Subclass 4 (IGG4)
Immunoglobulin M (IGM)
Prealbumin (PREALB)
Retinol Binding Protein (RBP)
soluble Transferrin Receptor (STFR)
Transferrin (TRF) [serum/plasma] and (TRF-U) [urine]
PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of α -Microglobulin (A1MIC), specialty Albumin (sALB*), Immunoglobulin G (IGG -C*), Microalbumin (MALB) and Transferrin (TRF-U**).
- For Cerebrospinal fluid (CSF)
** For urine
Product codes (comma separated list FDA assigned to the subject device)
DDG, JIX, JJY
Device Description
Dimension Vista® System TRF Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® System Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing q acid glycoprotein, a-antitrypsin, ß2-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocystine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.
Dimension Vista System Protein 3 Control
Protrein 3 Control is a multi-analyte, lyophilized, polygeline and rabbit plasma albumin based product containing a - Microglobulin, albumin, immunoglobulin G and transferrin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human serum, heparinized plasma, EDTA plasma, urine, Cerebrospinal fluid (CSF)
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)
Method Comparison Study
The Dimension Vista® System TRF assay was compared to the Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System by evaluating urine samples with concentrations ranging from 2.0 to 24.4 mg/L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Siemens Healthcare Diagnostics Inc. 510(k) Notification 9 Free System TRF Flex® reagent cartridge
Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control
AUG - 8 2008
510(k) Summary for Dimension Vista® System TRF Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K081299
-
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbH A Siemens Company Emil-von-Behring Str. 76 35041 Marburg, Germany |
|---|---|
| Contact Information: | Siemens Healthcare Diagnostics Inc. 500 GBD Drive Newark, Delaware 19702 Attn: Radames Riesgo Tel: 305.480.7558 Fax: 305.552.5288 |
| Preparation date: | May 7, 2008 |
| Device Name: | Dimension Vista® System TRF Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control |
|---|---|
| Classification: | Class II; Class II; Class I |
| Product Code: | DDG; JIX; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |
3. Identification of the Legally Marketed Device:
Dade Behring N Antisera to Human Transferrin~ K053075 Dade Behring N Protein Standard SL – K012470 Dade Behring N/T Protein Control LC - K032237
1
Siemens Healthcare Diagnostics Inc. 510(k) Notification e Poply Pictinous)
Dimension Vista® System Protein 1 Calibrator
Dimension Vista® System Protein 1 Calibrator
Dimension Vista® System Protein 1 Calibrator
Dimension Vista® Sy
4. Device Descriptions:
Dimension Vista® System TRF Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® System Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing q acid glycoprotein, a-antitrypsin, ß2-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocystine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.
Dimension Vista System Protein 3 Control
Protrein 3 Control is a multi-analyte, lyophilized, polygeline and rabbit plasma albumin based product containing a - Microglobulin, albumin, immunoglobulin G and transferrin.
5. Device Intended Uses:
Dimension Vista System TRF Flex® reagent cartridge:
The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Dimension Vista® System Protein 1 Calibrator:
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:
| α₁-Acid Glycoprotein
(A1AG) | Immunoglobulin G (IGG) [serum/plasma] and
(IGG-C) [cerebrospinal fluid] |
|--------------------------------|----------------------------------------------------------------------------|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G Subclass 1 (IGG1) |
| β₂-Microglobulin (B2MIC) | Immunoglobulin G Subclass 2 (IGG2) |
| C3 Complement (C3) | Immunoglobulin G Subclass 3 (IGG3) |
| C4 Complement (C4) | Immunoglobulin G Subclass 4 (IGG4) |
| Ceruloplasmin (CER) | Immunoglobulin M (IGM) |
| Haptoglobin (HAPT) | Prealbumin (PREALB) |
| Hemopexin (HPX) | Retinol Binding Protein (RBP) |
| Homocysteine (HCYS) | soluble Transferrin Receptor (STFR) |
| Immunoglobulin A (IGA) | Transferrin (TRF) [serum/plasma] and
(TRF-U) [urine] |
| Immunoglobulin E (IGE) | |
2
Siemens Healthcare Diagnostics Inc. 510(k) Notification e :