Syntron's QuikStrip DipScan X Multidrug Screening Device (the X is replaced by 2, 3, 4, 5, or 6) is a holder for up to six rapid, qualitative, competitive, binding immunoassay strips for the detection of drugs of abuse and their metabolites in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DipScan 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 spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's QuikStrip DipScan X Multidrug Screening Device is not intended to monitor drug levels, but only to screen for the presence of drugs of abuse and their metabolites.

Device Description

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 6 of the company's cleared drugs of abuse strips for the qualitative detection of drugs of abuse and their metabolites in a quick, simple, easy to read, screening format. Test strips available for inclusion in the DipScan X also comprises Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).

Syntron's QuikStrip DipScan X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, or 6) consists of two to six (2-6) individual test strips on which the drug or drug metabolites in the chromatographic absorbent device is immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up the support 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 test zone and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS (Note the cutoff for opiates used in the opiate test strips was 300 ng/ml instead of the new cutoff of 2000 ng/ml for opiates and in the 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. Test strips available for inclusion in the DipScan X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the QuikStrip DipScan X Multidrug Screening Device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to its ability to detect specific drugs of abuse or their metabolites in urine at SAMHSA (Substance Abuse and Mental Health Services Administration) designated GC/MS cutoff levels. The "reported device performance" is a general statement about the device's intended function rather than specific metrics in this document.

Acceptance Criteria (Implied)	Reported Device Performance
Qualitative detection of drugs/metabolites in urine.	The device is a "rapid, qualitative, competitive, binding immunoassay" for the detection of drugs of abuse in urine. It produces a magenta color band when the drug is below the detection level and no magenta color band when the drug is above the detection level.
Detection at SAMHSA designated GC/MS cutoff levels.	The device detects drugs "at the SAMHSA designated GC/MS cutoff levels." (Note: for Opiates, the 300 ng/ml cutoff was used instead of a newer, unspecified cutoff).
Specificity for various drugs of abuse.	The device is designed to detect Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP). "In-house testing... yielded no observations of inappropriate reactions or interference between tests."
Proper functioning of internal controls.	A magenta color band in the control zone demonstrates that reagents and the device are functioning correctly.
Individual strip independence.	"Each of the test strips in the holder functions independently and is read independently."
Not intended for quantitative monitoring of drug levels.	"Syntron's QuikStrip DipScan X Multidrug Screening Device is not intended to monitor drug levels, but only to provide preliminary data for the detection of drugs of abuse and their metabolites." This is a stated limitation and not a performance metric to be met, but rather a characteristic of the device's intended use.
Preliminary data requiring confirmation by other methods.	"The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)." This is a stated limitation and not a performance metric to be met, but rather a characteristic of the device's intended use and a recommendation for follow-up.

Study Details:

Sample Size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The text states "In-house testing," suggesting the data was generated internally by Syntron Bioresearch, Inc. The country of origin is implicitly the USA, where Syntron Bioresearch is located (Carlsbad, California). The study is retrospective in the sense that the data was generated prior to the 510(k) submission, but it's not explicitly stated if it was a retrospective analysis of existing samples or prospective testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth for cutoff levels is referenced to SAMHSA designated GC/MS cutoff levels, implying that these established external standards (likely from expert consensus or validated methods) serve as the ground truth.
Adjudication method for the test set:
- Not applicable/specified. The device is a qualitative diagnostic test that directly produces a positive/negative result based on a chemical reaction. The "ground truth" reference to SAMHSA GC/MS cutoffs suggests a comparison against an objective, established standard rather than human adjudication of interpretive results.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a MRMC study was not done. The device is a "screening device" that provides a "quick, simple, easy to read, screening format" with a direct visual output (presence or absence of a magenta band). It is designed for individual use and interpretation, not for complex medical imaging interpretation or scenarios where multiple human readers might disagree and benefit from AI assistance. Therefore, there's no discussion of human reader improvement with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the device's basic "in-house testing" provides standalone performance. The device itself performs the detection without human interpretive input beyond reading the color band. The description of how the device functions (antibody-dye conjugate binding, competition with immobilized antigen conjugate, magenta band indication) is a description of its standalone mechanistic operation.
The type of ground truth used:
- The primary ground truth referenced is SAMHSA designated GC/MS cutoff levels. This implies comparison to a highly accurate and standardized analytical method (Gas Chromatography/Mass Spectrometry), which is considered a gold standard for drug detection and quantification. The document mentions an exception for Opiates (300 ng/ml cutoff was used instead of a new cutoff), which suggests adherence to a specific, recognized standard.
The sample size for the training set:
- Not specified. The provided text describes the device and its intended use, along with limited "in-house testing" results. There is no mention of a "training set" in the context of machine learning or AI, as this device appears to be a chemical immunoassay, not an AI-driven diagnostic.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a "training set" or AI/machine learning aspects for this device. The device's mechanism is based on established immunochemical principles.

Summary

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K990335

510k Submission for QuikStrip DipScan X Multidrug Screening Device

Syntron Bioresearch. Inc.

Page 122 of 122

Revision d 06/17/99 Printed on 06/17/1999

Summary of Safety and Effectiveness 18.1

The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlishad, The sponsor, Syntrol Diotesearch, roured, and tested under GMP/GLP
California, 92008), has developed, manufactured, and the company's clearly California, 92005), has developed, mannovate 2 to 6 of the company's cleared
guidelines a Strip Holder that will accommodate 2 to 6 of drugs of shuge and guidelines a Strip Holder that will accomments of or vine of drugs of abuse and drugs of abuse strips for the quallative ato to read, screening format. Test strips
their metabolites in a quick, simple, success staming, Mathamphetamine their metabolizes in a quick, suippe, easy to roughetamine, Methampbetamine, a valiable for Inclusion in the Dipecal H allo imprises (THC), Opiates (300), and Phencyclidine (PCP).

The trade name of the device is QuikStrip DipScan X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, or 6) having a designated common Screening Device (x is replaced of the of the of Class II device per FDA. This name of Strip Holder and a classification as a sures of urine for drugs of abuse.
device is intended for the medical/forensic screening of wine (X is

Syntron's QuikStrip DipScan X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, or 6) consists of two to six (2-6) individual replaced by 2, 3, 4, 0, or of consisted or which the drug or drug metabolites in the chromatograppine absorbent ac vives in immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up a support the absorbent device, the labeled antibody-dye conjugate binda 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 officition of case and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS (Note the cutoff for 18 above used in the opiate test strips was 300 ng/ml instead of the new cutoff of opiaces and in the 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. Test strips available for inclusion in the DipScan X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).

In-house testing of QuikStrip DipScan X Multidrug Screening Device yielded no observations of inappropriate reactions or interference between tosts.

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/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling a person with outstretched arms, with three curved lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 4 1999

Syntron Bioresearch, Inc. c/o Cleve W. Laird, Ph.D. President and CEO Drial Consultants, Inc. 1420 Los Angeles Ave. Suite 201 Simi Valley, California 93065

K990325 Re: 15770729
Trade Name: QuikStrip DipScan X Multidrug Screening Device Regulatory Class: II Product Code: DKZ, DJC, DIS, JXM, LDJ, DIO, LCM, DJG Dated: May 11, 1999 Received: May 13, 1999

Dear Dr. Laird:

This letter corrects our substantially equivalent letter of June 24, 1999 regarding the incorrect trade name, QuikScan Drug Test X Multidrug Screening Device. Your June 7, mooreet trade name, Quikscan DipScan X Multidrug Scan X Multidrug Screening Device as the trade name.

We have reviewed your Section 510(k) notification of intent to market the device we nave it viewed your books armined 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 ni meetstate commerce provise has been reclassified in accordance with the provisions of Amendments of to de reeds and Cometic Act (Act). You may, therefore, market the device, the i cucral I ood, Drag, and Controls of the Act. The general controls provisions of the subject to the general email 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 (1 cinance rippro rar) it normaling can be found in the Code of Federal Regulations, Title 10 Parts 800 to 895. A substantially equivalent determination assumcs compliance with 21, I arts ooo to 0701 ing Practice requirements, as set forth in the Quality System the 000d Manatalians and Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug with the Citil Togalation in ther announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission docs not affect any obligation you might have under sections 531 through 542 of the Act

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Page 2

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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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): K990325

Device Name: QuikStrip DipScan X Multidrug Screening Device

Indications For Use:

Syntron's QuikStrip DipScan X Multidrug Screening Device (the X is replaced
) in the first and the commission will avolitative, competitive Syntron's QuikStrip DipScall a Michael ages common
by 2, 3, 4, 5, or 6) is a holder for up to six rapid, qualitative, competitive, in urine by 2, 3, 4, 5, or 6) is a notder for the decection of drugs of abserin urine at the
binding immunoassay strips for the detection of drugs of able for binding immunoassay strips for the access. The test strips available for
SAMHSA designated GCMS cutoff levels. The test strips available for SAMHSA designated GC/Mc Catch Promine, Methamphetamine,
inclusion in the DipScan are Amphetamine, Methamphetamine, inclusion in the Dipocan are Ampheraminer install (THC), Opiates, and Benzodiazepine, Barbiturates, Cocani, Marly preliminary data which
Phencyclidine (PCP).The tests provide only proliminary data which Phencychume (f Of ). Inter methods such as gas should be confirmed by oencr montometry (GCMS). Clinical chromatographymass spectryphisoment should be applied to any
considerations and professional judgment should minory positive considerations and professionial Jarga when preliminary positive
drug of abuse test result, particularly when DirScop X Multidrug drug of abuse test result, partics QuikStrip DipScan X Multidrug
results are indicated6. Syntron's QuikStrip drug levels, but only results are indicated. Syntron's camentor drug levels, but only to
Screening Device is not intended to monitor drugs and their Screening Device is not intended to misimaly of abuse and their metabolites.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dean Cooper

ion Sign-Off) Division of Clinical Laboratory ... vices 90325 510(k) Number

Prescription Use:
(Per 21 CFR 801.109

Over The Counter Use: (Optional Format 1-2-96)

Regulation Number and Section

§ 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).