(17 days)
Syntron's DrugCheck X Multidrug Screening Device (the X may be replaced by 2. 3. 4. 5. 6. 7. or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikStrip DrugCheck X Multidrug Screening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.
Syntron's DrugCheck X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, 6, 7, or 8) consists of two to eight (2-8) individual chromatographic absorbent devices in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex, different for each drug, competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. Each of the test strips in the holder functions independently and is read independently.
The provided text describes a 510(k) submission for the "QuikStrip DrugCheck X Multidrug Screening Device" by Syntron Bioresearch, Inc. This device is a strip holder for multiple immunoassay strips designed to detect drugs of abuse in urine.
Here's an analysis of the provided information against your requested criteria:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria (e.g., a predefined sensitivity or specificity threshold). However, it implies the acceptance criterion is that the device's performance should not be significantly different from established methods like Emit II or GC/MS.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Inappropriate reactions/interference | No observations of inappropriate reactions or interference between tests | No observations of inappropriate reactions or interference in in-house testing. Clinical trial of 565 samples revealed no inappropriate reactions or interference. |
| Statistical difference from reference methods (Emit II, GC/MS) | Not significantly different | Not significantly different from those obtained by either Emit II or GC/MS (non-parametric statistical methods). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 565 clinical samples.
- Data Provenance: Clinical samples (prospective, as it's a "clinical trial"). The country of origin is not explicitly stated, but the company is located in Carlsbad, California, USA, suggesting the data is likely from the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth.
4. Adjudication method for the test set
The document does not describe an adjudication method. It states that "All positive samples by either screening method were confirmed by GC/MS," implying GC/MS served as the definitive reference method, not an adjudicated consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a diagnostic test kit for drugs of abuse, not an AI-assisted diagnostic tool that requires human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone diagnostic device. The results (color bands) are read directly from the strips without an intermediate algorithm or human-in-the-loop interpretation being evaluated in the customary sense of an AI/human reader study. The "reading" of the strip is a direct visual assessment.
7. The type of ground truth used
- For positive samples: Gas Chromatography/Mass Spectrophotometry (GC/MS) was used for confirmation. This is a highly accurate and widely accepted gold standard for drug detection.
- For negative samples: The document doesn't explicitly state how negative ground truth was established, but typically this would also involve GC/MS or a panel of known negative samples.
8. The sample size for the training set
The document does not mention a separate "training set" in the context of machine learning. This is a traditional immunoassay device, not an AI/ML-based system that would typically have a distinct training and test set. In-house testing for interference and inappropriate reactions would have been part of the development and initial validation, but not a "training set" as understood in AI studies.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set as defined in AI/ML contexts. For the "in-house testing" mentioned, ground truth would have been established through controlled spiking of samples with known drug concentrations and confirmation with GC/MS.
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510k Submission for QuikStrip DrugCheck X Multidrug Screening Device Syntron Bioresearch, Inc.
Syntron Bioresearch, Inc.
Revision A 02/16/99 Printed on 6/11/99
Page 291 of 291
15.1 Summary of Safety and Effectiveness
The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West. Carlsbad. California, 92008), has developed, manufactured, and tested under GMP/GLP guidelines a Strip Holder that will accommodate 2 to 8 of the company's cleared drugs of abuse strips for the qualitative detection in urine of drugs of abuse and their metabolites in a quick, simple, easy to read, screening format,
The trade name of the device is DrugCheck X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, 6, 7, or 8) having a designated common name of Strip Holder and a classification as a Class II device per FDA. This device is intended for the medical/forensic screening of urine for drugs of abuse.
Syntron's DrugCheck X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, 6, 7, or 8) consists of two to eight (2-8) individual chromatographic absorbent devices in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex, different for each drug, competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. Each of the test strips in the holder functions independently and is read independently.
In-house testing of DrugCheck X Multidrug Screening Device yielded no observations of inappropriate reactions or interference between tests on samples designed to test for interference and inappropriate reactions. A clinical trial consisting of 565 clinical samples was run and the results revealed no inappropriate reactions or interference. The observations were not significantly different from those obtained by either Emit II or GCMS. When tested by non parametric statistical methods the results are not significantly different from one another. All positive samples by either screening method were confirmed by GC/MS.
Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President, Drial Consultants, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP -2 1999
Syntron Bioresearch. Inc. c/o Mr. James M. Barquest California Department of Health Food and Drug Branch 601 North Seventh Street (MS-357) P.O. Box 942732 Sacramento, California 94234
Re: K992748
Trade Name: QuikStrip DrugCheck X Multidrug Screening Device Regulatory Class: II Product Code: DIO, LDJ, DKZ, DPK, LCM Dated: August 9, 1999 Received: August 16, 1999
Dear Mr. Barquest:
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
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 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 Putman
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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510(k) Number (if Known): Not Yet Assigned
Device Name: DrugCheck X Multidrug Screening Device
Indications For Use:
Syntron's DrugCheck X Multidrug Screening Device (the X may be replaced by 2. 3. 4. 5. 6. 7. or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikStrip DrugCheck X Multidrug Screening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.
Deantosey
(Division Sign-Off)
Division of Clinical Laboratory Devices Kyo777 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
Prescription Use:
(Per 21 CFR 801.109
5000
Over The Counter Use: (Optional Format 1-2-96)
FOOD & DRUG BRANCH JUN 1 8 1999
or
§ 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).