(12 days)
Not Found
No
The summary describes a homogeneous enzyme immunoassay for digoxin analysis and mentions only minor packaging differences from the predicate device. There is no mention of AI or ML technology in the intended use, device description, or the specific sections for AI/ML mentions.
No
The device is an in vitro diagnostic assay used for quantitative analysis of digoxin in human serum or plasma to aid in diagnosis and monitoring, not for direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section states, "Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy." This directly indicates its role in diagnosis.
No
The device description explicitly states it is a "homogeneous enzyme immunoassay" and describes physical components like "reagents," "reagent bottles," and "barcode label." It also mentions compatibility with "OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers," which are hardware devices. This indicates it is a physical assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative analysis of digoxin in human serum or plasma." This is a test performed on samples taken from the human body in vitro (outside the body).
- Purpose: The measurements are used "in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy." This directly relates to medical diagnosis and treatment decisions based on the results of the in vitro test.
- Device Description: The description details reagents and their use on analyzers, which are typical components of an IVD system.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or treatment. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
Product codes
KXT
Device Description
The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Emit® 2000 Digoxin Assay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.
0
JUL - 2 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® 2000 Digoxin Assay
Manufacturer and Contact Information: ﮩ
| Manufacturer: | Syva Company – Dade Behring Inc.
20400 Mariani Ave.
Cupertino, CA 95014 |
| --------------- | ------------------------------------------------------------------------------- |
|---|
Susan L. Collins Contact Information: Regulatory Affairs Syva Company - Dade Behring, Inc. 20400 Mariani Avenue Cupertino, CA 95014 Tel: 408 - 366-3908 Fax: 408 - 366-3725
- Date Summary Prepared: 2. June 19, 2001
Device Trade Name: 3. Emit® 2000 Digoxin Assay
Common Name: ৰ্ব Enzyme Immunoassay, Digoxin
5. Device Classification Name:
The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Digoxin test system" as Class II, 21 CFR Part 862.3320, 91 KXT.
6. Intended Use:
The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
7. Device Description:
The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
8. Substantial Equivalence
The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. In conclusion the modified Emit® 2000 Digoxin Assay is substantially equivalent to the predicate Emit® 2000 Digoxin Assay.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 2 2001
Ms. Susan L. Collins Regulatory Affairs Syva Company - Dade Behring Inc. 20400 Mariani Avenue Cupertino, CA 95014
510(k) Number: K011920 Re: Trade/Device Name: Emit® 2000 Digoxin Assay Regulation Number: 862.3320 Regulatory Class: II Product Code: KXT Dated: June 19, 2001 Received: June 20, 2001
Dear Ms. Collins:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 (Frenances in provide in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing 11 becommany of a variaes: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
2
Page 2
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 noutication. The FDA inding of baction 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 CFF Part 801 and IT you desire specific advice to: your as ic devices), please contact the Office of Compliance at additionally 607.10 for in This dagliestions on the promotion and advertising of your device, (301) 594-4588. Additionally, for quose at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnel tax 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 Putman
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
3
Indications for Use Statement
Device Name: Emit® 2000 Digoxin Assay 510(k) Number (if known): Koll920
Indications for Use:
The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
Fred Lacy
(Division Sign-Off) Division of Clinical Laboratory Devices Koll920 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)