(45 days)
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No
The document describes a standard enzyme immunoassay for detecting cocaine metabolites in urine and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic assay used to detect cocaine metabolites in human urine, providing analytical test results rather than direct therapy or treatment.
Yes
The device is described as an immunoassay intended for the qualitative and semi-quantitative analysis of a cocaine metabolite in human urine, which provides a preliminary analytical test result used for diagnosis.
No
The device is a homogeneous enzyme immunoassay intended for use with chemistry analyzers, indicating it is a chemical reagent-based assay and not solely software.
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 analyses of benzoylecgonine (cocaine metabolite) in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description reinforces this by stating it's a "homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis of cocaine metabolite (benzoylecgonine) in human urine."
- Performance Studies: The document includes performance studies comparing the device to a predicate device and a confirmatory method (GC/MS), which is typical for IVD submissions.
- Predicate Device: A predicate device (Emit® II Plus Cocaine Metabolite Assay) is listed with a K number (K011162), indicating a previous FDA clearance for a similar IVD device.
All these points strongly indicate that the Emit® II Plus Monoclonal Cocaine Metabolite Assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Emit® II Plus Monoclonal Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Monoclonal Cocaine Metabolite 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
DIO
Device Description
Emit® Il Plus Monoclonal Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis of cocaine metabolite (benzoylecgonine) in human unne.
Mentions image processing
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: Qualitative Results
150 ng/mL CUTOFF:
One hundred and ten (110) samples were analyzed by the Emit® II Plus Monoclonal Cocaine Metabolite Assay and the Emit® II Plus Cocaine Metabolite Assay on the SYVA®-30R Biochemical System. Forty-six (46) samples showed positive results by both methods, and 60 samples showed negative results by both methods. Of the forty-six (46) specimens showing positive results by the Emite II Plus Monoclonal Cocaine Metabolite Assay, forty-two (42) were confirmed by GC/MS to contain cocaine metabolite between 150 ng/mL and greater than 1000 ng/mL benzoylecgonine. Four samples showed positive with comparative method but negative with Emit® II Plus Monoclonal Cocaine Metabolite Assay, which were shown to contain 25, 46, 99 and 110 ng/mL benzovlecgonine as determined by GC/MS.
Of the one hundred (110) method comparison samples, 19% were within ±25% of the cutoff value. Percent Agreement: 96%
300 ng/mL CUTOFF:
One hundred and ten (110) samples were analyzed by the Emit® II Plus Monoclonal Cocaine Metabolite Assay and the Emit II Plus Cocaine Metabolite Assay on the SYVA®-30R Blochemical System. Twenty-nine (29) samples showed positive results by both methods, and seventy-nine (79) samples showed negative results by both methods. Of the twenty-nine (29) samples showing positive by Emit® II Plus Monoclonal Cocaine Metabolite Assay, twenty-eight (28) were confirmed by GC/MS to contain cocaine metabolite between 300 ng/ml_ and greater than 1000 ng/mL benzoylecgonine. Two samples showed negative with Emit® II Plus Monoclonal Cocaine Metabolite Assay but positive with comparative method, which were shown to contain 218 and, 235 ng/mL benzoylecgonine as determined by GC/MS.
Of the one hundred (110) method comparison samples, 16% were within ±25% of the cutoff value. Percent Agreement: 98%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent Agreement: 96% (for 150 ng/mL cutoff); Percent Agreement: 98% (for 300 ng/mL cutoff)
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
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Syva Company - Dade Behring Inc 510(k) Notification - K02044 Additional Information
MAR 2 8 2002
510(k) Summary for Emit® II Plus Monoclonal Cocaine Metabolite Assay
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.
The assigned 510(k) number is: KO2O 44 |
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
Manufacturer:
Syva Company - Dade Behring Inc. 20400 Mariani Ave Cupertino, CA 95014
Contact Information:
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date:
March 26, 2002
2. Device Name/ Classification:
Emit® Il Plus Monoclonal Cocaine Metabolite Assay: Cocaine and cocaine metabolite test system Class II (862.3250)
91 DIO Product Code:
Identification of the Legally Marketed Device: 3.
Emit® II Plus Cocaine Metabolite Assay (K011162)
4. Device Description:
Emit® II Plus Monoclonal Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis of cocaine metabolite (benzoylecgonine) in human unne.
1
Syva Company - Dade Behring Inc. 510(k) Notification - KD20441 Additional Information
Device Intended Use: 5.
The Emit® II Plus Monoclonal Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Monoclonal Cocaine Metabolite 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.
- Medical device to which equivalence is claimed and comparison information: હ. The modified Emil® II Plus Monoclonal Cocaine Metabolite Assay is substantially equivalent in intended use to the Emit® II Plus Cocaine Metabolite Assay currently marketed. The modified Emit® II Plus Monoclonal Cocaine Metabolite Assay, like the current Emit® II Cocaine Metabolite Assay is intended to be used for the qualitative and semi-quantitative analyses of cocaine metabolite (benzoylecgonine) in human urine.
7. Device Performance Characteristics:
Method Comparison:
Qualitative Results
150 ng/mL CUTOFF
One hundred and ten (110) samples were analyzed by the Emit® II Plus Monoclonal Cocaine Metabolite Assay and the Emit® II Plus Cocaine Metabolite Assay on the SYVA®-30R Biochemical System. Forty-six (46) samples showed positive results by both methods, and 60 samples showed negative results by both methods. Of the forty-six (46) specimens showing positive results by the Emite II Plus Monoclonal Cocaine Metabolite Assay, forty-two (42) were confirmed by GC/MS to contain cocaine metabolite between 150 ng/mL and greater than 1000 ng/mL benzoylecgonine. Data are summarized in the table below.
Comparative Method | ||
---|---|---|
+ | - | |
+ | 46 | 0 |
- | 4 * | 60 |
Qualitative Results for the 150 ng/mL Cutoff
- Shown to contain 25, 46, 99 and 110 ng/mL benzovlecgonine as determined by GC/MS.
Of the one hundred (110) method comparison samples, 19% were within ±25% of the cutoff value. Percent Agreement: 96%
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Syva Company - Dade Behring Inc. 51 D(k) Notification - K020441 Additional Information
300 ng/mL CUTOFF
One hundred and ten (110) samples were analyzed by the Emit® II Plus Monoclonal Cocaine Metabolite Assay and the Emit II Plus Cocaine Metabolite Assay on the SYVA®-30R Blochemical System. Twenty-nine (29) samples showed positive results by both methods, and seventy-nine (79) samples showed negative results by both methods. both memods, and seventy-line (10) Samplos Showed Nogative Togation of Sun Monoclonal Cocaine Metabolite Assay, twenty-eight (28) were confirmed by GC/MS to contain cocaine metabolite between 300 ng/ml_ and greater than 1000 ng/mL benzoylecgonine. Data are summarized in the table below.
Qualitative Results for the 300 ng/mL Cutoff
Comparative Method | |||
---|---|---|---|
+ | - | ||
+ | 29 | 0 | |
Emit® II Plus | |||
Monoclonal | |||
Cocaine Metabolite | |||
Assay | - | 2 * | 79 |
- Shown to contain 218 and, 235 ng/mL benzoylecgonine as determined by GC/MS.
Of the one hundred (110) method comparison samples, 16% were within ±25% of the cutoff value.
Percent Agreement: 98%
0000008
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird with three stylized lines representing its wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 8 2002
Ms. Kathleen A. Dray-Lyons Manager, Regulatory Affairs and Compliance Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714
Re: K020441
Trade/Device Name: Emit ® II Plus Monoclonal Cocaine Metabolite Assay Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: February 8, 2002 Received: February 11, 2002
Dear Ms. Dray-Lyons:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 i 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 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
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
5
dditional Information
Indications Statement
Device Name:
Emit® II Plus Monoclonal Cocaine Metabolite Assay
Indications for Use:
The Emit® II Plus Monoclonal Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Monoclonal Cocaine Metabolite 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-ofabuse test result, particularly when preliminary positive results are used.
D.R.
Division of Clinical Laboratory Devices KO20441 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)
Over-The-Counter-Use (Optional Format 1-2-96)
0000004