(42 days)
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No
The summary describes a standard in vitro diagnostic test and calibrator for measuring iron levels, with no mention of AI or ML technologies.
No
The device is described as an "in vitro diagnostic product" and "in vitro diagnostic device" used for measuring iron levels, which is for diagnosis, not therapy.
Yes
The text explicitly states "The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma." and "Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism." It also refers to the device as "an in vitro diagnostic device".
No
The device description clearly states it is an in vitro diagnostic device consisting of prepackaged reagents in a plastic cartridge and an aqueous solution in glass vials, indicating it is a hardware-based system with chemical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma." It also mentions its use in the diagnosis and treatment of diseases.
- Device Description: Describes the reagent cartridge and calibrator as "in vitro diagnostic device" and "in vitro diagnostic product" respectively.
- Performance Studies: The performance studies are conducted to demonstrate substantial equivalence to predicate devices which are also IVDs (as indicated by the K numbers and names).
The document consistently uses the term "in vitro diagnostic" and describes the device's function as measuring analytes in human samples for diagnostic purposes, which are key characteristics of an IVD.
N/A
Intended Use / Indications for Use
The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista TM system.
Product codes (comma separated list FDA assigned to the subject device)
JIY, JIS
Device Description
The Dimension Vista™ IRON Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension Vista ™ system for the quantitative determination of iron in serum and plasma.
The Dimension Vista™ Iron Calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit contains three glass screw top vials, 1.0 mL each, of the Calibrator A (1075 ug/dL).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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AUG - 7 2006
510(k) Summary for the Dimension Vista™ IRON Flex® reagent cartridge
A. 510(k) Number:
- B. Analyte: Total iron
- C. Type of Test: Quantitative
D. Applicant:
Manufacturer: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101
Contact: Andrea M. Tasker, Regulatory Affairs and Compliance Manager (302) 631-9454
Date of Preparation: June 23, 2006
E. Proprietary and Established Names:
Dimension Vista™ IRON Flex® reagent cartridge
F. Regulatory Information:
- l . Regulation section: 21 CFR §862.1410 Iron (non-heme) test system
- Classification: Class I 2.
-
- Product Code: JIY
- Panel: Chemistry (75) 4.
G. Intended Use:
- Intended for Use:
The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma.
2. Indications for Use:
The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
-
- Special condition for use statement(s): none
-
- Special instrument Requirements: Dimension Vista ™ system
1
H. Device Description:
The Dimension Vista™ IRON Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension Vista ™ system for the quantitative determination of iron in serum and plasma.
I. Substantial Equivalence Information:
- Predicate Device: Dimension® Iron Flex® reagent cartridge (IRON- DF85)
-
- Predicate K Number(s): K060264
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | Quantitative determination of total iron | same |
| Reagent components | Ferene® (chromophore) | |
| Thiourea (prevent Cu interference) | ||
| Ascorbic acid (reducing agent) | same | |
| Measurement method | Bi-chromatic endpoint measurement (600 and 700 nm) | same |
| Calibration | linear calibration | same |
| Assay Range | 0 to 1,000 μg/dL | same |
| Sample Types | Serum and Heparin plasma | same |
| Standardization | NIST SRM 937 | same |
| Differences | ||
| Item | Device | Predicate |
| Sample Volume | 20uL | 40uL |
3. Comparison with Predicate:
J. Standard/Guidance Document Referenced
- Guidance;
Calibration Scheme
Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
3 levels in triplicate
A New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
2 levels in duplicate
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
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2. Standards:
Medical Devices - Symbols to be used with medical device labeling and information to be supplied (15223). General, ISO
Medical devices - Application of risk management to medical devices (14971:2000) General, ISO Stability Testing of In Vitro Diagnostic Reagents (13640), InVitro, CEN
Continuous Quality Improvement: Essential Management Approaches: Approved Guideline (GP 22-A). InVitro, NCCLS
Interference Testing in Clinical Chemistry; Approved Guideline (EP 7-A), InVitro, NCCLS Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition (EP5-A2), InVitro, CLSI
Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP09-A2), InVitro, NCCLS
K. Test Principle:
The automated Dimension Vista™ IRON method is an adaptation of direct iron assays using the chromophore Ferene ® . Under acidic conditions, iron (Fe+++) bound to the protein transferrin is released. In the presence of the reducing agent ascorbic acid, (Fe+++) is reduced to (Fe++). (Fe ++) forms a blue complex with 3-(2-pyridy))-5.6-bis-2-(5-fury) sulfonic acid)-1,2,4-triazine, disodium salt (Ferene®). The absorbance of the complex. measured using a bichromatic (600. 700 nm) endpoint technique, is directly proportional to the concentration of transferrin-bound iron in the serum.
L. Comments on Substantial Equivalence/Conclusion:
The performance testing according to the verification and validation test protocols demonstrate that the Dimension Vista™ IRON Flex® reagent cartridge is substantially equivalent to the designated predicate device.
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510(k) Summary for the Dimension Vista™ IRON Calibrator
A. 510(k) Number:
- B. Analyte: Iron Calibrator
- C. Type of Test: Calibrator Material
D. Applicant:
Manufacturer: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101
Contact: Andrea M. Tasker, Regulatory Affairs and Compliance Manager (302) 631-9454
Date of Preparation: June 23, 2006
E. Proprietary and Established Names:
Dimension Vista™ Iron Calibrator
F. Regulatory Information:
-
Regulation section: 21 CFR § 862-1150 - CALIBRATOR
-
Classification: Class II
-
Product Code: JIS - CALIBRATORS, PRIMARY
4. Panel: CLINICAL CHEMISTRY
G. Intended Use:
l. Intended use(s):
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista TM system.
- Indication(s) for use:
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista TM system.
-
Special condition for use statement(s): none
-
Special instrument Requirements: none
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H. Device Description:
The Dimension Vista™ Iron Calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit contains three glass screw top vials, 1.0 mL each, of the Calibrator A (1075 ug/dL).
. Substantial Equivalence Information:
-
- Predicate Device: Dimension® Iron Calibrator (DC85)
-
- Predicate K Number(s): K060266
3. Comparison with Predicate:
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | To calibrate the iron method | same |
| Traceability | NIST SRM 937 (NIST SRM: National | |
| Institute of Standards and | ||
| Technology- Standard Reference | ||
| Material) | same | |
| Matrix | Aqueous solution of iron wire | |
| dissolved in a dilute solution of HCl | same |
J. Standard/Guidance Document Referenced:
- Guidance;
Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
A New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
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2. Standards;
Medical Devices - Symbols to be used with medical device labels, labeling and information to be supplied (15223), General, ISO Medical devices - Application of risk management to medical devices (14971:2000) General, ISO Stability Testing of In Vitro Diagnostic Reagents (13640), InVitro, CEN Continuous Quality Improvement: Essential Management Approaches; Approved Guideline (GP 22-A), InVitro, NCCLS
K. Test Principle:
The Dimension Vista™ Iron Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension Vista™ IRON method for the Dimension Vista™ system.
L . Comments on Substantial Equivalence/Conclusion:
The performance testing according to the verification and validation test protocols demonstrate that the Dimension Vista™ Iron Calibrator is substantially equivalent to the designated predicate device.
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Andrea M. Tasker Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Business Community PO Box 6101, MS 514 Newark DE 19714-6101
Re: K061793
Trade/Device Name: Dimension Vista™ IRON Flex® reagent cartridge Dimension Vista™ IRON Calibrator Regulation Number: 21 CFR8862.1410 Regulation Name: Iron (non-heme) test system Regulatory Class: Class I Product Code: JIY, JIT Dated: July 21, 2006 Received: July 24, 2006
AUG - 7 2006
Dear Ms. Tasker:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutiér
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
510(k) Number (if known):
Device Name: IRON Flex® reagent cartridge
Indications for Use:
The iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
Prescription Use __ X (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
Page 12
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Carol C. Benam
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K061793
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Indications For Use Statement
510(k) Number (if known):
Device Name: Kold793
Dimension Vista™ IRON Calibrator
Indications for Use:
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista "system.
Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
Page 2 of 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off
Office of In Vit-o Diagnostic Device Evaluation and Safety