(64 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric analysis, with no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is an in vitro diagnostic (IVD) device used for the qualitative and semiquantitative analysis of cocaine metabolites in human urine, which provides preliminary analytical test results for drug screening, not for treatment or therapy.
Yes
The device is intended for the qualitative and semiquantitative analyses of a cocaine metabolite in human urine, providing a preliminary analytical test result for drug-of-abuse testing. This falls under the definition of a diagnostic device as it is used to identify the presence of a substance in a biological sample.
No
The device description clearly states it is a "ready-to-use, liquid reagent, homogeneous enzyme immunoassay," 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 the analysis of benzoylecgonine (cocaine metabolite) in human urine. This is a biological sample taken from the human body.
- Device Description: The description details a homogeneous enzyme immunoassay that uses specific antibodies to detect a substance in a biological sample (urine). This is a common method used in IVD devices.
- Function: The device performs a test on a sample taken in vitro (outside the body) to provide information about the presence of a substance related to a physiological state (drug use).
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help detect, diagnose, monitor, or treat disease or other conditions. This device fits that definition.
N/A
Intended Use / Indications for Use
The Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine.
The Cocaine Metabolite Enzyme Immunoassay 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. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Product codes
DIO
Device Description
LZI's Cocaine Metabolite Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect benzovlecgonine (cocaine metabolite) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between benzoylecgonine labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device's performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity were evaluated.
Performance Characteristics Summary:
- Within Run Precision (Qualitative):
- Negative: Mean Rate 243.7, SD 0.9, % CV 0.37
- 225 ng/mL: Mean Rate 356.8, SD 1.8, % CV 0.50
- 300 ng/mL: Mean Rate 380.2, SD 1.8, % CV 0.48
- 375 ng/mL: Mean Rate 397.3, SD 2.2, % CV 0.56
- 3000 ng/mL: Mean Rate 488.4, SD 1.8, % CV 0.36
- Within Run Precision (Semi-quantitative):
- 225 ng/mL: Mean Conc. 226.2, SD 3.3, % CV 1.45
- 300 ng/mL: Mean Conc. 303.4, SD 4.6, % CV 1.53
- 375 ng/mL: Mean Conc. 370.7, SD 5.1, % CV 1.37
- Run-To-Run Precision (Qualitative):
- Negative: Mean Rate 243.1, SD 0.9, % CV 0.36
- 225 ng/mL: Mean Rate 354.8, SD 2.4, % CV 0.67
- 300 ng/mL: Mean Rate 377.0, SD 3.5, % CV 0.93
- 375 ng/mL: Mean Rate 394.6, SD 2.1, % CV 0.53
- 3000 ng/mL: Mean Rate 486.0, SD 2.4, % CV 0.49
- Run-To-Run Precision (Semi-quantitative):
- 225 ng/mL: Mean Conc. 226.7, SD 3.2, % CV 1.41
- 300 ng/mL: Mean Conc. 307.9, SD 5.1, % CV 1.65
- 375 ng/mL: Mean Conc. 376.8, SD 6.9, % CV 1.83
- Sensitivity: 4 ng/mL
- Accuracy (Vs. DRI s Cocaine Metabolite EIA): Sensitivity 100 %, Specificity 100 %
- Analytical Recovery:
- Qualitative: 100 % accuracy on positive vs. negative tests
- Semi-quantitative: Quantitate within ±10% of the nominal concentration between 30 ng/mL and 2100 ng/mL. Average 100.6 % recovery at 225 ng/mL level (Cutoff -25%) Average 97.3 % recovery at 375 ng/mL level (Cutoff + 25%)
- Specificity: Comparable to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 4 ng/mL
Accuracy (Vs. DRI s Cocaine Metabolite EIA): Sensitivity 100 %, Specificity 100 %
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
MAY 1 0 2002
1020763
510(k) Summary of Safety and Effectiveness
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.
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, Address, and Contact
Lin-Zhi International, Inc. 2391 Zanker Road, Suite 340 San Jose, CA 95131-1124 Phone: (408) 944-0360 (408) 944-0359 Fax:
Chiu Chin Chang, Ph.D. Contact: VP, R&D
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Cocaine and Cocaine Metabolites,
Class II, DIO (91 Toxicology), 21CFR 862.3250 |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous enzyme immunoassay for the determination of
benzoylecgonine (cocaine metabolite) level in urine. |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.' Cocaine Metabolite Enzyme Immunoassay is substantially equivalent to the Cocaine Metabolite Enzyme Immunoassay (By DRI/Microgenics Corp.), cleared under premarket notification K960187.
LZI's Cocaine Metabolite Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
LZI's Cocaine Metabolite Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect benzovlecgonine (cocaine metabolite) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
1
The assay is based on competition between benzoylecgonine labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine.
Comparison to Predicate Device
LZI's Cocaine Metabolite Enzyme Immunoassay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed Cocaine Metabolite Enzyme Immunoassay (K960187) by Diagnostic Reagents, Inc. (DRI, now Microgenics Corporation)
The following table compares LZI's Cocaine Metabolite Enzyme Immunoassay with the predicate device, DRI's Cocaine Metabolite Enzyme Immunoassay. Specific data on the performance of the test have been incorporated into the proposed product insert (Attachment A). Product inserts for the predicate device and two other commercial products of similar intended use are provided in the Attachment C.
Similarities:
- Both assays are for qualitative and semi-quantitative determination of . benzovlecgonine (cocaine metabolite) in human urine.
- Both assays use the same method principle, and device components. .
- Both assays use 300 ng/mL as cutoff level per recommendations of The Substance . Abuse and Metal Health Services Administration (SAMHSA).
Differences:
- . Assay range for the DRI's assay is 0 to 1000* ng/mL; LZI's assay range is 0 to 3000 ng/mL.
- LZI's Cocaine Metabolite Enzyme Immunoassay uses 5 calibrators for the semi-. quantitative analysis of benzovlecgonine (cocaine metabolite) concentration in urine. DRI's Cocaine Metabolite EIA used 3 calibrators previously. A total of 5 calibrators are available now from DRI.
- Previously DRI assay range was also 0 to 3000 ng/mL as indicated in its product insert of 03/98.
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(Comparison to Predicate Device, continued)
Performance Characteristics
| Feature | DRI's Cocaine Metabolite EIA | LZI's Cocaine Metabolite EIA | ||||||
|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | ||||||||
| Qualitative: | Negative | Mean Rate | SD | % CV | Negative | Mean Rate | SD | % CV |
| Negative | 302 | 2.0 | 0.7 | Negative | 243.7 | 0.9 | 0.37 | |
| 225 ng/mL | 341 | 2.5 | 0.7 | 225 ng/mL | 356.8 | 1.8 | 0.50 | |
| 300 ng/mL | 354 | 3.4 | 0.9 | 300 ng/mL | 380.2 | 1.8 | 0.48 | |
| 375 ng/mL | 374 | 2.4 | 0.6 | 375 ng/mL | 397.3 | 2.2 | 0.56 | |
| *3000 ng/mL | 442 | 3.6 | 0.8 | 3000 ng/mL | 488.4 | 1.8 | 0.36 | |
| Semi-quantitative: | No data available. | Mean Conc. | SD | % CV | ||||
| 225 ng/mL | 226.2 | 3.3 | 1.45 | |||||
| 300 ng/mL | 303.4 | 4.6 | 1.53 | |||||
| 375 ng/mL | 370.7 | 5.1 | 1.37 | |||||
| Run-To-Run Precision: | ||||||||
| Qualitative: | Negative | Mean Rate | SD | % CV | Negative | Mean Rate | SD | % CV |
| Negative | 302 | 3.9 | 1.3 | Negative | 243.1 | 0.9 | 0.36 | |
| 225 ng/mL | 342 | 3.9 | 1.1 | 225 ng/mL | 354.8 | 2.4 | 0.67 | |
| 300 ng/mL | 354 | 4.9 | 1.4 | 300 ng/mL | 377.0 | 3.5 | 0.93 | |
| 375 ng/mL | 374 | 5.1 | 1.4 | 375 ng/mL | 394.6 | 2.1 | 0.53 | |
| *3000 ng/mL | 443 | 5.2 | 1.2 | 3000 ng/mL | 486.0 | 2.4 | 0.49 | |
| Semi-quantitative: | No data available. | Mean Conc. | SD | % CV | ||||
| 225 ng/mL | 226.7 | 3.2 | 1.41 | |||||
| 300 ng/mL | 307.9 | 5.1 | 1.65 | |||||
| 375 ng/mL | 376.8 | 6.9 | 1.83 | |||||
| Sensitivity: | 40 ng/mL | 4 ng/mL | ||||||
| Accuracy: | Vs. a commercial EIA | Vs. DRI s Cocaine Metabolite EIA | ||||||
| Sensitivity | 100 % | 100 % | ||||||
| Specificity | 100 % | 100 % | ||||||
| Analytical Recovery: | ||||||||
| Qualitative: No data available | 100 % accuracy on positive vs. negative tests | |||||||
| Semi-quantitative: No data available | Quantitate within ±10% of the nominal | |||||||
| concentration between 30 ng/mL and 2100 | ||||||||
| ng/mL. | ||||||||
| Average 100.6 % recovery at 225 ng/mL | ||||||||
| level (Cutoff -25%) | ||||||||
| Average 97.3 % recovery at 375 ng/mL level | ||||||||
| (Cutoff + 25%) | ||||||||
| Specificity: | See attached DRI's Cocaine Metabolite | |||||||
| EIA package insert | Comparable to the predicate device. |
*Data from 03/98 package insert. The assay range for DRI assay now is 0 to 1000 ng/mL.
3
Conclusion
LZI's Cocaine Metabolite Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. onatuelers showed acceptable results when compared to the predicate device.
We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Cocaine Metabolite Enzyme Immunoassay to other cocaine metabolite test systems currently marketed in the United States.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 0 2002
Chiu Chin Chang, Ph.D. VP. R&D Lin-Zhi International, Inc. 2391 Zanker Road, Suite 340 San Jose, CA 95131-1124
K020763 Re:
Trade/Device Name: Cocaine Metabolite Enzyme Immunoassay Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: April 15, 2002 Received: April 24, 2002
Dear Dr. Chang:
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 for abound in the 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 may or sabyeet to been to deeal 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 r rouse of a read a determination that your device complies with other requirements of the Act and in Drederal statutes and regulations administered by other Federal agencies. You must or any 1 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 Of A rate 677) working (21 CFR Part 820); and if applicable, the electronic forth in the qualis) 35 would 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 ' 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/cdrh/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
6
Premarket Notification
Indications for Use Statement
510(k) Number (if known): KO 20763
Device Name: Cocaine Metabolite Enzyme Immunoassay
Indications for Use:
The Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine.
The Cocaine Metabolite Enzyme Immunoassay 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. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Pan Coopy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020763
Concurrence of CDRH, Office of Device Evaluation (ODE)
$\checkmark$
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)