(212 days)
Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect benzoylecgonine, a metabolite of cocaine in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.
This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory-method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
This test is a one-step lateral flow chromatographic immunoassay.
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:
Device: Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for overall performance. Instead, it reports the performance achieved and then concludes that based on these results, the device is suitable and substantially equivalent.
However, we can infer performance metrics that were evaluated and achieved:
| Performance Metric | Reported Device Performance |
|---|---|
| Correlation with predicate device (QuikStrip One Step Cocaine Test, K971926) | Higher than 92.9% |
| Agreement across three POL sites (for correlation study) | 93.3% |
| Accuracy (against expected results) in Clinical Laboratory and three POL sites | 97.8% |
| Suitability for use by healthcare professionals with diverse educational backgrounds and work experiences | Concluded as suitable based on accuracy evaluation results from both clinical lab and POL sites, conducted by persons with diverse educational backgrounds and working experience. This implies the device demonstrated ease of use and consistent results regardless of user background. |
| Cutoff level | Detects Benzoylecgonine at a cutoff level of 300 ng/ml |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices Laboratory." It also references "Raw Data for Accuracy Study from the three POL sites and the Reference Laboratory" and "Tabulated Results (Ascending Concentration) of the Accuracy Study... with the GC/MS Data". However, the specific number of samples used in the accuracy study (test set) is not explicitly stated in the provided text.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, and the Toxicology Laboratory (Unilab Corporation) is located in Tarzana, CA, USA. This suggests the data is likely from the USA.
- Retrospective or Prospective: Not explicitly stated. Given the nature of a 510(k) submission for a diagnostic device, these are typically prospective studies where samples are collected and tested using the new device and a reference method. However, without explicit mention, it cannot be definitively confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: The document details an "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices Laboratory conducted by persons with diverse educational backgrounds and working experience". However, it does not specify the number of individual experts or operators involved in establishing the ground truth or conducting the studies, beyond referring to "persons" and "diverse educational backgrounds and working experience."
- Qualifications: While it mentions "diverse educational backgrounds and working experience" for those conducting the evaluation, it does not provide specific qualifications like "radiologist with 10 years of experience." The context implies these are healthcare professionals or laboratory personnel. The reference laboratory (Unilab Corporation, Toxicology Laboratory) provides the gold standard GC/MS data, implying their staff are qualified in toxicology analysis.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The accuracy study compares the device's results against "results expected" which are derived from a "Reference Laboratory" using GC/MS data. This suggests a direct comparison to a gold standard, rather than a concensus among multiple human readers of the device itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs without AI assistance. This device is a rapid diagnostic test (cassette immunoassay), not an AI-assisted diagnostic tool that would typically involve human readers interpreting complex images or data with or without AI assistance. Therefore, this section is not applicable to the submitted device.
6. Standalone (Algorithm Only) Performance
This device is a standalone immunoassay cassette test. Its performance inherently represents its "standalone" (algorithm only) capability for detecting Benzoylecgonine. There is no separate "human-in-the-loop" component to consider for this type of test, distinct from the test itself being operated by a person. The reported accuracy and correlation data reflect its standalone performance.
7. Type of Ground Truth Used
The primary ground truth used for the accuracy study was:
- GC/MS Data (Gas Chromatography/Mass Spectrophotometry): This is explicitly mentioned as the "preferred confirmatory method" and the "GC/MS Data the Toxicology Laboratory" was used in the Accuracy Study. This is generally considered a highly accurate and definitive method for drug detection and quantification in toxicology.
- Predicate Device Comparison: Correlation with a legally marketed predicate device (QuikStrip One Step Cocaine Test) also served as a comparative ground truth.
8. Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI components. The Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test is described as a "one-step lateral flow chromatographic immunoassay," which is a traditional laboratory diagnostic device, not an AI/ML-based device that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML model, this question is not applicable to the described device.
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Alfa Scientific Designs, Inc.
11494 Sorrento Valley Road, S San Diego, CA 92121
510(K) Summary
In accordance with the Safe Medical Devices Act of 1990, a 510(K) summary is provided as outlined in 21 CFR 807.92.
| Submitter | Name: | Alfa Scientific Designs, Inc. |
|---|---|---|
| Address: | 11494 Sorrento Valley Road, Suite MSan Diego, CA 92121Telephone: (858) 350-9798Fax: (858) 350-9709Email: asdi@worldnet.att.net) | |
| Device Name | Trade Name: Instant-View™ Cocaine (Benzoylecgonine)Urine Cassette Test | |
| Common Name: Cocaine Test | ||
| Classification Name: 21 CFR 862.3250, Class II | ||
| Predicate Device | The Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test is substantially equivalent to other legallymarketed devices for the similar intended use. The deviceused for comparison study is QuikStrip One Step CocaineTest, manufactured by Syntron Bioresearch, Inc. with510(K) #: K971926, Date of Approval: 07/14/97. | |
| Device Description | This test is a one-step lateral flow chromatographicimmunoassay. | |
| Intended Use | The Instant-View™ Cocaine (Benzoylecgonine) UrineCassette Test is a qualitative immunoassay device intendedto detect Benzoylecgonine in human urine at a cutoff levelof 300 ng/ml. It is intended for health care professional useonly. | |
| Summary of theSimilarities to thePredicate Device | • Intended Use: | Both devices are intended to detect Benzoylecgonine inhuman urine at a cutoff level of 300 ng/ml.• Interpretation of results:The appearance of only one - C line, indicates a positiveresult, and that the Benzoylecgonine level is at a cutofflevel of 300 ng/ml or higher. And, the appearance of two |
| lines – both C line and T line indicates a negative result,and that the Benzoylecgonine level is below 300 ng/ml.• Technological Characteristics:• Both devices are one step, qualitative, competitivebinding immunoassay test, utilizing the basicimmunochemical sandwich assay principle ofrecognition and formation of the specificBenzoylecgonine/Antibody/Benzoylecgonine complexes. | ||
| Discussion andConclusion | • The correlation of results from the Instant-View™Cocaine (Benzoylecgonine) Urine Cassette Test, and thelegally marketed test device compared, is higher than92.9 %. The results from the three POL sites agreed93.3 %. | |
| • The Accuracy Evaluation results from the ClinicalLaboratory and the three Physician's Offices Laboratoryconducted by persons with diverse educationalbackgrounds and working experience agreed 97.8 % withthe results expected. | ||
| • Based on the results of the Performance Characteristicsand Comparison Studies, it may be concluded that theInstant-View™ Cocaine (Benzoylecgonine) UrineCassette Test is suitable for use by health careprofessionals with diverse educational backgrounds andwork experiences, and it is substantially equivalent to theexisting legally marketed device. |
510(K) Summary: K994398 Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test
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Additional Information:
- Package Insert of the Predicate Device. A:
- Records of Raw Data from the In-House Sensitivity Study B:
- Raw Data for Precision Study from the three different POL sites. C:
- Raw Data for Accuracy Study from the three POL sites and the Reference D: Laboratory.
- Tabulated Results (Ascending Concentration) of the Accuracy Study form the E: Tabulaton (results (risemans ) Laboratory with the GC/MS Data the Toxicology Laboratory.
Source of Clinical Samples: Unilab Corporation
Toxicology Laboratory 18408 Oxnard Street Tarzana, CA 91356 Tel: (818) 996-7300 Fax: (818) 345-6967 Contact Person: Ali Mikhchi
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 three overlapping, abstract shapes that resemble a bird in flight or flowing ribbons.
JUL 2 7 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rhoda Filipina QA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121
K994398 Re:
Trade Name: Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test Regulatory Class: II Product Code: DIO Dated: June 30, 2000 Received: July 6, 2000
Dear Ms. Filipina:
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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
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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 yours,
Steven Dutman
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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K994398 510(k) Number (if known):
Device Name: Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test
Indications For Use:
Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect benzoylecgonine, a metabolite of cocaine in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.
This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory-method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
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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) | |
|---|---|
| ----------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K994398 |
§ 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).