(98 days)
P890025
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No
The device description details a homogeneous enzyme immunoassay technique based on antibody binding and spectrophotometric measurement, which is a standard biochemical method and does not involve AI or ML. The performance studies use linear regression for data analysis, which is a statistical method, not AI/ML. There are no mentions of AI, ML, or related concepts in the document.
No
The device is an in vitro diagnostic assay used for quantitative analysis of cyclosporine in human whole blood, which aids in managing cyclosporine therapy. It does not directly provide therapy.
Yes
Explanation: The device is described as an "in vitro quantitative analysis of cyclosporine (CsA) in human whole blood as an aid in the management of cyclosporine therapy," which directly indicates its use for diagnostic purposes to aid in patient management.
No
The device description clearly outlines a homogeneous enzyme immunoassay technique involving reagents (antibodies, enzyme, NAD) and spectrophotometric measurement, indicating a physical assay kit and associated hardware for analysis, not a software-only device.
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 assay is "for in vitro quantitative analysis of cyclosporine (CsA) in human whole blood". The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The description details a laboratory-based assay using reagents and spectrophotometric measurement to analyze a sample (whole blood). This is characteristic of an in vitro diagnostic test.
- Sample Type: The assay is performed on "human whole blood," which is a biological specimen collected from a patient for analysis.
- Purpose: The assay is used "as an aid in the management of cyclosporine therapy," indicating its role in providing diagnostic information to guide clinical decisions.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transplant tissues, organs, or blood.
N/A
Intended Use / Indications for Use
The Emit® 2000 Cyclosporine Specific Assay is for in vitro quantitative analysis of cyclosporine (CsA) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart and liver transplant patients.
Product codes
MKW
Device Description
The Emit® 2000 Cyclosporine Specific Assay employs a homogeneous enzyme immunoassay technique used for the analysis of cyclosporine in whole blood. The assay contains mouse monoclonal antibodies with a high specificity for cyclosporine.
The Emit® 2000 Cyclosporine Specific Assay is based on competition for cyclosporine antibody binding sites. Cyclosporine in the sample competes with cyclosporine in Enzyme Reagent B that is labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH). Active (unbound) enzyme converts the oxidized nicotinamide adenine dinucleotide (NAD) in Antibody Reagent A to NADH, resulting in a kinetic absorbance change that can be measured spectrophotometrically. Enzyme activity decreases upon binding to the antibody, allowing the cyclosporine concentration in the sample to be measured in terms of enzyme activity. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
Mentions image processing
Not Found
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
Method comparison studies were conducted at two external sites comparing the extended range Emit® 2000 Cyclosporine Specific Assay against two predicates:
- the Abbott TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood Assay, and .
- liquid chromatography / mass spectrometry (LC/MS) .
Banked retrospective samples from 3 transplant patient groups (heart, liver and kidney) were used in the studies. The data from both sites were pooled and analyzed by linear regression.
Comparative Method with LC/MS:
All samples: Slope=1.01, Intercept=36.07, r=0.971, n=138
Heart: Slope=1.04, Intercept=19.00, r=0.989, n=33
Liver: Slope=1.00, Intercept=42.11, r=0.971, n=40
Kidney: Slope=1.14, Intercept=-49.0, r=0.951, n=59
Comparative Method with Abbott TDx®/TDx/FLx® CSA Monoclonal Whole Blood Assay:
All samples: Slope=1.13, Intercept=-92.4, r=0.969, n=134
Heart: Slope=1.12, Intercept=-86.6, r=0.976, n=33
Liver: Slope=1.14, Intercept=-102, r=0.982, n=40
Kidney: Slope=1.15, Intercept=-114, r=0.950, n=59
Key Metrics
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Predicate Device(s)
Abbott TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood Assay, P890025
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1235 Cyclosporine test system.
(a)
Identification. A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.
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-EB G 2006
510(k) Summary Emit® 2000 Cyclosporine Specific Assay
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Manufacturer:
Contact Information:
Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation: Oct. 14, 2005
2. Device Name / Classification
Emit® 2000 Cyclosporine Specific Assay / Class II
3. Identification of the Predicate Device
Abbott TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood Assay, P890025
4. Device Description
The Emit® 2000 Cyclosporine Specific Assay employs a homogeneous enzyme immunoassay technique used for the analysis of cyclosporine in whole blood. The assay contains mouse monoclonal antibodies with a high specificity for cyclosporine.
The Emit® 2000 Cyclosporine Specific Assay is based on competition for cyclosporine antibody binding sites. Cyclosporine in the sample competes with cyclosporine in Enzyme Reagent B that is labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH). Active (unbound) enzyme converts the oxidized nicotinamide adenine dinucleotide (NAD) in Antibody Reagent A to NADH, resulting in a kinetic absorbance
1
change that can be measured spectrophotometrically. Enzyme activity decreases upon binding to the antibody, allowing the cyclosporine concentration in the sample to be measured in terms of enzyme activity. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
5. Device Intended Use
The Emit® 2000 Cyclosporine Specific Assay is for in vitro quantitative analysis of cyclosporine (CsA) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart and liver transplant patients.
6. Medical device to which equivalence is claimed and comparison information
The Emit® 2000 Cyclosporine Specific Assay is substantially equivalent in intended use and technological characteristics to the Abbott TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood Assay. Both devices are immunoassays intended for use in the quantitative measurement of cyclosporine in human whole blood. The Emit® 2000 Cyclosporine Specific Assay has an assay range of 40-500 ng/mL or 350-2000 ng/m1. The Abbott TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood Assay has an assay range of 25-1500 ng/mL
Comparison Information
Method comparison studies were conducted at two external sites comparing the extended range Emit® 2000 Cyclosporine Specific Assay against two predicates:
- the Abbott TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood Assay, and .
- liquid chromatography / mass spectrometry (LC/MS) .
Banked retrospective samples from 3 transplant patient groups (heart, liver and kidney) were used in the studies. The data from both sites were pooled and analyzed by linear regression.
Comparative Method
| LC/MS | Slope | Intercept | r | n |
|---|---|---|---|---|
| All samples | 1.01 | 36.07 | 0.971 | 138 |
| Heart | 1.04 | 19.00 | 0.989 | 33 |
| Liver | 1.00 | 42.11 | 0.971 | 40 |
| Kidney | 1.14 | -49.0 | 0.951 | 59 |
| Abbott TDx®/TDx/FLx® CSA Monoclonal Whole Blood Assay | ||||
| All samples | 1.13 | -92.4 | 0.969 | 134 |
| Heart | 1.12 | -86.6 | 0.976 | 33 |
| Liver | 1.14 | -102 | 0.982 | 40 |
| Kidney | 1.15 | -114 | 0.950 | 59 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)", which is arranged in a circular fashion around the symbol.
Public Health Service
FEB 6 2006 Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Yuk-Ting Lewis Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 M/S 514 Newark, DE 19714
Re: K053061
Trade/Device Name: Emit®2000 Cyclosporine Specific Assay Regulation Number: 21 CFR§ 862.1235 Regulation Name: Cyclosporine test system Regulatory Class: Class II Product Code: MKW Dated: January 6, 2006 Received: January 13, 2006
Dear Yuk-Ting:
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
Alberto Gutierrez, Ph.D.
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
510(k) Number (if known):
Emit® 2000 Cyclosporine Specific Assay Device Name:
Indications For Use:
The Emit® 2000 Cyclosporine Specific Assay is for in vitro quantitative analysis of cyclosporine therany in kidney, The Emit® 2000 Cyclosportifie Spective Assay is for in Ville qualified by the first of the management of cyclosporine therapy in kidney, heart and liver transplant patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ana Choppie
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Office of In Vitro Diagnostic Device _valuation and Safety
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