(19 days)
Not Found
K/DEN number:
No
The summary describes a homogeneous enzyme immunoassay for quantitative analysis of quinidine, with modifications related to packaging and compatibility with specific analyzers. There is no mention of AI or ML in the intended use, device description, or any of the "Mentions" sections.
No.
The device is an in vitro diagnostic assay used for quantitative analysis of quinidine levels to monitor therapy or diagnose overdose, not to directly treat a condition.
Yes
Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose.
No
The device description explicitly states it is a homogeneous enzyme immunoassay with reagents packaged in bottles, indicating it is a chemical 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 quinidine in human serum or plasma." This involves testing biological samples outside of the body.
- Purpose: The measurements are used "in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine to ensure appropriate therapy." This directly relates to providing information for medical diagnosis and treatment decisions.
- Method: It is described as a "homogeneous enzyme immunoassay," which is a common technique used in in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
Product codes
LBZ
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
JUN 1 2 2001
KO11605
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® 2000 Quinidine Assay
1. Manufacturer and Contact Information:
Manufacturer:
Syva Company - Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014
Contact Information:
Susan L. Collins Requiatory Affairs Syva Company - Dade Behring, Inc. 3403 Yerba Buena Road San Jose, CA 95135 Tel: 408 - 239 - 4412 Fax: 408 - 239 - 2348
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- Date Summary Prepared: May 22, 2001
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- Device Trade Name: Emit® 2000 Quinidine Assay
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- Common Name: Enzyme Immunoassay, Quinidine
5. Device Classification Name:
The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Quinidine test system" as Class II, 21 CFR Part 862.3320.
6. Intended Use:
The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine 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 Quinidine Assay is substantially equivalent to the predicate Emit® 2000 Quinidine Assay.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
JUN 1 2 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Susan L. Collins Regulatory Affairs Syva Company-Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95135
510(k) Number: K011605 Re: Trade/Device Name: Emit® 2000 Quinidine Assay Regulation Number: 862.3320 Regulatory Class: II Product Code: LBZ Dated: May 22, 2001 Received: May 24, 2001
Dear Ms. Collins:
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 to 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 Good Manufacturing Practice for Medical Devices: 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
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to organizatial equivalence of your device to a legally marketed noutication. The I D7X Incing of backing 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 additionally 607.10 for in This alagitestions on the promotion and advertising of your device, (201) 594-4566. Frauncently, at (301) 594-4639. Also, please note the regulation prease condor and office creference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your responsibility the 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
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Indications for Use Statement
Device Name: Emit® 2000 Quinidine Assay 510(k) Number (if known): KO11605
Indications for Use:
The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine 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 K011605 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)