(31 days)
Not Found
No
The device description details a standard turbidimetric assay based on chemical reactions and optical measurements, with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies also focus on traditional statistical metrics like correlation and slope, not metrics typically associated with AI/ML performance.
No
This device is an in vitro diagnostic test designed to measure immunoglobulin G in serum and plasma, not to treat or diagnose a disease.
Yes
The "Intended Use / Indications for Use" states that the device is an "in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma," fulfilling the definition of a diagnostic device.
No
The device is a reagent cartridge for a clinical chemistry system, which is a physical component used in a laboratory setting to perform a diagnostic test. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma." This is the defining characteristic of an IVD.
- Device Description: The description details a laboratory test performed on biological samples (serum and plasma) to measure a specific analyte (IgG). This is consistent with the nature of an IVD.
- Performance Studies: The inclusion of performance studies comparing the device to a predicate device (another IVD) further confirms its classification as an IVD.
The information provided clearly indicates that this device is designed to be used outside of the body to examine specimens from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or for the assessment of health.
N/A
Intended Use / Indications for Use
The IGG Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure immunoglobulin G (IgG) in human serum and plasma.
The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.
Product codes
CFO
Device Description
The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgG by its polyclonal antibodies.a
IgG from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgG and it is calculated from a five point calibration curve.
PEG IgG + Antibody --------------------------> IgG-Antibody Complex
a The antibody is manufactured by Dade Behring, Marburg, Germany
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
Split sample comparison between the IGG Flex™ reagent cartridge and the Beckman Immunoglobulin G assay gave a correlation coefficient of 0.993, slope of 1.00, and an intercept of -12.8 mg/dL when tested with 111 clinical patient samples.
Key Metrics
correlation coefficient of 0.993, slope of 1.00, and an intercept of -12.8 mg/dL
Predicate Device(s)
Beckman Array® Immunoglobulin G Method (K922273)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
3/25/99
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
DADE BEHRING
Summary of Safety and Effectiveness Information
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.
| Submitter's Name: | Cathy P. Craft
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | February 16, 1999 |
| Name of Product: | IGG Flex™ Reagent Cartridge |
| FDA Classification Name: | Immunoglobulin G Test System |
| Predicate Device: | Beckman Array® Immunoglobulin G Method (K922273) |
Device Description: The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgG by its polyclonal antibodies.a
IgG from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgG and it is calculated from a five point calibration curve.
PEG IgG + Antibody --------------------------> IgG-Antibody Complex
a The antibody is manufactured by Dade Behring, Marburg, Germany
Intended Use: The IGG Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure immunoglobulin G (IgG) in human serum and plasma.
Comparison to Predicate Device:
| Item | IGG Flex™ Reagent Cartridge | Beckman Array® IgG |
|---|---|---|
| Sample Type | Serum and plasma | Serum |
| Methodology | Immunoprecipitation | Immunoprecipitation |
| Detection | Bichromatic endpoint | |
| (340 and 700 nm) | ||
| (turbidimetry) | Nephelometry | |
| (405 nm) |
1
Comments on Substantial Equivalence:
Split sample comparison between the IGG Flex™ reagent cartridge and the Beckman Immunoglobulin G assay gave a correlation coefficient of 0.993, slope of 1.00, and an intercept of -12.8 mg/dL when tested with 111 clinical patient samples.
The IGG Flex™ reagent cartridge is substantially equivalent in principle and Conclusion: performance to the Beckman Immunoglobulin G Assay based on the split sample comparison discussed above.
Cary PCraft
Cathy P. Craft
Regulatory Affairs and Compliance Manager Date: February 16, 1999
2
Image /page/2/Picture/1 description: The image is a black and white 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. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The text is in all capital letters.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 5 1999
Ms. Cathy P. Craft Regulatory Affairs and Compliance Manager DADE Behring, Inc. Chemistry Group P.O. Box 6101 Route 896, Glasgow Bldg. 500 Newark, Delaware 19714-6101
Re: K990551
Trade Name: DIMENSION® Immunoglobulin IgG FLEX™ Reagent Cartridge Regulatory Class: II Product Code: CFO Dated: February 16, 1999 Received: February 22, 1999
Dear Ms. Craft:
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.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 predicate 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/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
4
Indications For Use Statement
Device Name: IGG Flex™ Reagent Cartridge
Indications for Use:
The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.
Cathy P. Craft Regulatory Affairs and Compliance Manager
February 16, 1999
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tetin E. Matson
1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
(Division Sign-Off Division of Clinical Laboratory De 510(k) Number
Prescription Use_1 (Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)