(16 days)
Not Found
OLYMPUS® AU400/600™, AU800/1000™, AU2700™ Series Analyzers
No
The summary describes a homogeneous enzyme immunoassay for drug testing, focusing on reagent packaging and compatibility with analyzers. There is no mention of AI or ML.
No
This device is an immunoassay intended for qualitative and semi-quantitative analysis of amphetamines in human urine, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "Amphetamine Assay" intended for "qualitative and semi-quantitative analysis of amphetamines in human urine," which directly indicates its use in determining the presence and approximate concentration of a substance in a biological sample to aid in diagnosis or screening.
No
The device is a homogeneous enzyme immunoassay with reagents and packaging, 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 "qualitative and semi-quantitative analysis of amphetamines in human urine." This is a diagnostic test performed on a sample taken from the human body (urine) to provide information about a person's health status (presence of amphetamines).
- Sample Type: The device analyzes "human urine," which is a biological sample.
- Purpose: The purpose is to detect the presence of a substance (amphetamines) in the sample, which is a key characteristic of an in vitro diagnostic test.
The fact that it's a "homogeneous enzyme immunoassay" and provides a "preliminary analytical test result" further confirms its nature as a laboratory-based diagnostic test.
N/A
Intended Use / Indications for Use
The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/ml cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analysis of amphetamines in human urine. These reagents are packaged specifically for use on a variety of Olympus® analyzers.
The Emit® II Plus Monoclonal Amphetamine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Product codes
DKZ, LAF
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
human urine
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)
Emit® II Plus Monoclonal Amphetamine/Methampe Assay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
AUG - 3 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay
1. Manufacturer and Contact Information:
| 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 - 366-3840 Fax: 408 - 366-3725
-
- Date Summary Prepared:
July 17, 2001
- Date Summary Prepared:
3. Device Trade Name:
Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay
4. Common Name:
Enzyme Immunoassay, Methamphetamine Enzyme Immunoassay, Amphetamine
5. Device Classification Name:
The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Methamphetamine test system" as Class II, 21 CFR Part 862.3610, 91LAF and "Amphetamine test system" as Class II, 21 CFR 862.3100, 91DKZ.
6. Intended Use:
The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/ml cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analysis of amphetamines in human urine. 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® II Plus Monoclonal Amphetamine/Methamphetamine Assay is substantially equivalent to the predicate Emit® II Plus Monoclonal Amphetamine/Methampe Assay.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
AUG - 3 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Susan L. Collins Regulatory Affairs Syva Company-Dade Behring Inc. 20400 Mariani Avenue Cupertino, CA 95014
510(k) Number: K012257 Re: STO(K) Namocional Provis Monoclonal Amphetamine/Methamphetamine Assay Regulation Number: 862.3610, 862.3100 Regulatory Class: II Product Code: DKZ, LAF Dated: July 17, 2001 Received: July 18, 2001
Dear Ms. Collins:
We have reviewed your Section 510(k) notification of intent to market the device referenced wo have lovice four bothed 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 1 court I ood, Drog, and consist of the Act. The general controls provisions of the Act include the general volusiness 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 (1 remancer repression) 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 r raction of inspections, the Food and Drug Administration (FDA) will verify such periodio Ship may regulation may regulation may result in regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I DIA may pachase to your premarket notification submission does not affect reemer. Freason 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 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" (21CFR 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 vours.
Steven Butman
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 หัวเลวรา
510(k) Number (if known):
Device Name: Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay
Indications for Use:
The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/ml cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analysis of amphetamines in human urine. These reagents are packaged specifically for use on a variety of Olympus® analyzers.
The Emit® II Plus Monoclonal Amphetamine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K612257
(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)