(73 days)
No
The device description clearly states it is a lateral flow immunochromatographic assay based on antigen-antibody immunochemistry and can be performed without an instrument. There is no mention of AI or ML in the description, performance studies, or key metrics.
No.
The device is for the detection of drugs in human urine, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is described as a rapid chromatographic immunoassay for the qualitative and simultaneous detection of various substances in human urine, with the stated "Intended Use / Indications for Use" being the detection of these substances. This aligns with the definition of a diagnostic device, which is used to identify a condition, disease, or in this case, the presence of specific substances.
No
The device description clearly states it is a "rapid chromatographic immunoassay" and a "competitive binding, lateral flow immunochromatographic assay," which are hardware-based test methods. It also describes physical components like a "control region (CTL)" and "membrane wicking."
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and simultaneous detection of [various drugs] in human urine." This involves testing a sample taken from the human body (in vitro) to provide diagnostic information (detection of drugs).
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes antibodies to detect substances in a human specimen (urine). This is a common characteristic of IVD devices.
- Clinical Evaluation: The document describes a clinical evaluation using "clinical urine specimens" to compare the device's performance against other methods (GC/MS and predicate devices). This type of evaluation is standard for demonstrating the performance of IVD devices.
- Predicate Devices: The listed predicate devices are all single-drug tests intended for detecting substances in human urine, which are also IVDs.
The core function of the device is to analyze a biological sample (urine) outside of the body to provide information about the presence of specific substances, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACON TRI-fect" Drug Screen Test Device is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine at cut-off concentrations:
- 1,000 ng/mL Amphetamine 300 ng/mL Barbiturates 300 ng/mL Benzodiazepines 300 ng/mL Cocaine 50 ng/mL Marijuana 500 ng/mL Methylenedioxymethamphetamine 300 ng/mL Opiates 100 ng/mL Oxycodone 25 ng/mL Phencyclidine 300 ng/mL Propoxyphene 1,000 ng/mL Tricyclic Antidepressants
They are intended for healthcare professional use only including professionals at the point of care sites.
This assay 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 spectrometry (GC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of Onlinour ocholderly when preliminary positive results are used.
Product codes
DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN, LFG
Device Description
The ACON TRI-fect" Drug Screen Test Device is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine.
The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibodies to selectively detect elevated levels of Amphetamine, Barbiturates, Benzodiazepines. Cocaine. Marijuana. Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing the drug concentration below the cut-off level will generate a colored-line in the designated test region for the drug. To serve as a procedural control, a colored line will always appear at the control region (CTL), indicating that sufficient volume of specimen applied and proper membrane wicking occurred. If a control line fails to develop during testing, the test becomes invalid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional use only including professionals at the point of care sites.
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
A clinical evaluation was conducted using clinical urine specimens. 1,704 clinical specimens were employed including approximately 10% of the samples with drug concentrations in the -25% to +25% cut-off range. The evaluation compared the test results between the ACON TRI-fect™ Drug Screen Test Device versus previously FDA-cleared Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants Single tests; as well as against data obtained from the customary GC/MS analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical evaluation and comparison study.
Sample Size: 1,704 clinical urine specimens.
Key Results: The study compared the ACON TRI-fect™ Drug Screen Test Device results to GC/MS analysis data. The results showed high positive, negative, and overall agreement for each of the eleven drugs tested.
- AMP (Amphetamine): Positive Agreement 99%, Negative Agreement 98%, Overall Agreement 98%
- BAR (Barbiturates): Positive Agreement 98%, Negative Agreement 99%, Overall Agreement 99%
- BZO (Benzodiazepines): Positive Agreement 96%, Negative Agreement >99%, Overall Agreement 98%
- COC (Cocaine): Positive Agreement >99%, Negative Agreement 95%, Overall Agreement 96%
- THC (Marijuana): Positive Agreement 96%, Negative Agreement 95%, Overall Agreement 95%
- MDMA (Methylenedioxymethamphetamine): Positive Agreement >99%, Negative Agreement 99%, Overall Agreement 99%
- OPI (Opiates): Positive Agreement >99%, Negative Agreement 97%, Overall Agreement 98%
- OXY (Oxycodone): Positive Agreement 99%, Negative Agreement 99%, Overall Agreement 99%
- PCP (Phencyclidine): Positive Agreement 99%, Negative Agreement 99%, Overall Agreement 99%
- PPX (Propoxyphene): Positive Agreement >99%, Negative Agreement >99%, Overall Agreement >99%
- TCA (Tricyclic Antidepressants): Positive Agreement >99%, Negative Agreement 93%, Overall Agreement 94%
The study concluded that the ACON TRI-fect™ Drug Screen Test Device demonstrated substantial equivalency to the predicate single drug tests and is safe and effective for detecting the specified drugs at the given cut-off concentrations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The key metrics presented are Positive Agreement, Negative Agreement, and Overall Agreement, which are analogous to Positive Percent Agreement, Negative Percent Agreement, and Overall Percent Agreement.
| ACON Test Device | Positive Agreement | Negative Agreement | Overall Agreement |
|---|---|---|---|
| AMP | 134/136 = 99% | ||
| (95% - 99%)* | 308/314 = 98% | ||
| (96% - 99%)* | 442/450 = 98% | ||
| (97% - 99%)* | |||
| BAR | 99/101 = 98% | ||
| (93% - 99%) | 305/309 = 99% | ||
| (97% - 99%)* | 404/410 = 99% | ||
| (97% - 99%)* | |||
| BZO | 135/140 = 96% | ||
| (92% - 99%)* | 308/310 > 99% | ||
| (98% - 99%)* | 443/450 = 98% | ||
| (97% - 99%)* | |||
| COC | 119/119 > 99% | ||
| (97% - 99%)** | 308/325 = 95% | ||
| (92% - 97%)* | 427/444 = 96% | ||
| (94% - 98%)* | |||
| THC | 116/121 = 96% | ||
| (91% - 99%)* | 311/327 = 95% | ||
| (92% - 97%)* | 427/448 = 95% | ||
| (93% - 97%)* | |||
| MDMA | 88/88 > 99% | ||
| (96% - 99%)** | 301/305 = 99% | ||
| (97% - 99%)* | 389/393 = 99% | ||
| (97% - 99%)* | |||
| OPI | 140/140 > 99% | ||
| (97% - 99%)** | 300/309 = 97% | ||
| (95% - 99%)* | 440/449 = 98% | ||
| (96% - 99%)* | |||
| OXY | 140/141 = 99% | ||
| (96% - 99%)* | 306/309 = 99% | ||
| (97% - 99%)* | 446/450 = 99% | ||
| (98% - 99%)* | |||
| PCP | 85/86 = 99% | ||
| (94% - 99%)* | 300/304 = 99% | ||
| (97% - 99%)* | 385/390 = 99% | ||
| (97% - 99%)* | |||
| PPX | 145/146 > 99% | ||
| (96% - 99%)* | 304/304 > 99% | ||
| (99% - 99%)** | 449/450 > 99% | ||
| (99% - 99%)* | |||
| TCA | 32/32 > 99% | ||
| (89% - 99%)** | 316/338 = 93% | ||
| (90% - 96%)* | 348/370 = 94% | ||
| (91% - 96%)* |
- Denotes 95% confidence interval.
** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.
Predicate Device(s)
K011673, K012824, K012300, K010841, K003557, K022589, K013380, K033047, K011730, K040445, K021526
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SEP - 9 2004
SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS 8.
This summary of 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 K04 1743 ______________________________________________________________________________________________________________________________________________________________________________
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel .: 858-535-2030 Fax: 858-535-2038
Date:
June 23, 2004
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® TRI-fect™ Drug Screen Test Device
Common Name:
Immunochromatographic test for the simultaneously qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine.
Device Classification:
The ACON TRI-fect™ Drug Screen Test Device is similar to other FDA-cleared devices for the qualitative and simultaneous detection of drugs in urine specimens. These drug tests are used only to provide a preliminary analytical result. The test systems have been classified as Class II devices with moderate complexity. Product codes DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN and LFG have been assigned for the test system.
1
Classification Name:
Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants test systems
Intended Use:
The ACON TRI-fect" Drug Screen Test Device is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine at cut-off concentrations:
- 1,000 ng/mL Amphetamine 300 ng/mL Barbiturates 300 ng/mL Benzodiazepines 300 ng/mL Cocaine 50 ng/mL Marijuana 500 ng/mL Methylenedioxymethamphetamine 300 ng/mL Opiates 100 ng/mL Oxycodone 25 ng/mL Phencyclidine 300 ng/mL Propox yphene 1,000 ng/mL Tricyclic Antidepressants
They are intended for healthcare professional use only including professionals at the point of care sites.
Description:
The ACON TRI-fect" Drug Screen Test Device is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine.
The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibodies to selectively detect elevated levels of Amphetamine, Barbiturates, Benzodiazepines. Cocaine. Marijuana. Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing the drug concentration below the cut-off level will generate a colored-line in the designated
2
test region for the drug. To serve as a procedural control, a colored line will always appear at the control region (CTL), indicating that sufficient volume of specimen applied and proper membrane wicking occurred. If a control line fails to develop during testing, the test becomes invalid.
Predicate Devices
Cocaine, Benzodiazepines, Marijuana, Barbiturates, ACON Amphetamine, Methylenediox ymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants Single Drug Test Strips were used as the predicate devices for the ACON TRI-fect" Drug Screen Test Device to compare their performance with clinical urine specimens.
510(k) Numbers for these predicate devices are:
| ACON AMP One Step Amphetamine Test Strip: | K011673 |
|---|---|
| ACON BAR One Step Barbiturates Test Strip: | K012824 |
| ACON BZO One Step Benzodiazepine Test Strip: | K012300 |
| ACON COC One Step Cocaine Test Strip: | K010841 |
| ACON THC One Step Marijuana Test Strip: | K003557 |
| ACON MDMA One Step Ecstasy Test Strip: | K022589 |
| ACON MOP One Step Opiates Test Strip: | K013380 |
| ACON OXY One Step Oxycodone Test Strip: | K033047 |
| ACON PCP One Step Phencyclidine Test Strip: | K011730 |
| ACON PPX One Step Propoxyphene Test Strip: | K040445 |
| ACON TCA One Step Tricyclic Antidepressants Test Strip: | K021526 |
Comparison to a Predicate Device:
A comparison of the features of the ACON® TRI-fect™ Drug Screen Test Device versus the ACON One Step Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants Single Tests is shown below:
- . Both tests are immunoassays intended for the qualitative detection of Amphetamine, Benzodiazepines, Cocaine, Marijuana, Methylenedioxy-Barbiturates, methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in urine samples.
- Both tests are intended as a screening method that provides a preliminary analytical test result.
- Both tests are immunochromatographic, lateral flow assays for the rapid detection Barbiturates, Benzodiazepines, Cocaine, Marijuana, Amphetamine, of Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants and their derivatives with a visual,
3
qualitative end result, while the ACON® TRI-fect™ Drug Screen Test detects 2 to 11 of the above drugs simultaneously.
- Both tests utilize the same basic immunoassay principles that rely on antigen/ . antibody interactions to indicate a positive or a negative result.
- . Both tests have the same cut-off concentration for a specific drug tested.
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using clinical urine specimens. This evaluation compared the test results between the ACON TRI-fect™ Drug Screen Test Device versus FDA-cleared Amphetamine, Barbiturates, Benzodiazepines, Cocaine, previously Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants Single tests; as well as against data obtained from the customary GC/MS analysis. 1,704 clinical specimens were employed including approximately 10% of the samples with drug concentrations in the -25% to +25% cut-off range. The comparisons of data obtained from this study yielded the following results:
Clinical study results of the ACON TRI-fect™ Drug Screen Test Device are compared to GC/MS analysis data.
The GC/MS cut-off levels for each of the eleven drugs tested are as follows:
| Amphetamine | 1,000 ng/mL |
|---|---|
| Barbiturates | 300 ng/mL |
| Benzodiazepines | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Opiates | 300 ng/mL |
| Oxycodone | 100 ng/mL |
| Phencyclidine | 25 ng/mL |
| Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressants | 1,000 ng/mL |
Samples with drug concentration above the cut-off level were considered presumptive positive and concentrations below the cut-off are considered negative.
4
ACON TRI-fect™ Drug Screen Test Device vs. GC/MS Analysis
| ACON Test Device | Positive Agreement | Negative Agreement | Overall Agreement |
|---|---|---|---|
| AMP | 134/136 = 99% | ||
| (95% - 99%)* | 308/314 = 98% | ||
| (96% - 99%)* | 442/450 = 98% | ||
| (97% - 99%)* | |||
| BAR | 99/101 = 98% | ||
| (93% - 99%) | 305/309 = 99% | ||
| (97% - 99%)* | 404/410 = 99% | ||
| (97% - 99%)* | |||
| BZO | 135/140 = 96% | ||
| (92% - 99%)* | 308/310 > 99% | ||
| (98% - 99%)* | 443/450 = 98% | ||
| (97% - 99%)* | |||
| COC | 119/119 > 99% | ||
| (97% - 99%)** | 308/325 = 95% | ||
| (92% - 97%)* | 427/444 = 96% | ||
| (94% - 98%)* | |||
| THC | 116/121 = 96% | ||
| (91% - 99%)* | 311/327 = 95% | ||
| (92% - 97%)* | 427/448 = 95% | ||
| (93% - 97%)* | |||
| MDMA | 88/88 > 99% | ||
| (96% - 99%)** | 301/305 = 99% | ||
| (97% - 99%)* | 389/393 = 99% | ||
| (97% - 99%)* | |||
| OPI | 140/140 > 99% | ||
| (97% - 99%)** | 300/309 = 97% | ||
| (95% - 99%)* | 440/449 = 98% | ||
| (96% - 99%)* | |||
| OXY | 140/141 = 99% | ||
| (96% - 99%)* | 306/309 = 99% | ||
| (97% - 99%)* | 446/450 = 99% | ||
| (98% - 99%)* | |||
| PCP | 85/86 = 99% | ||
| (94% - 99%)* | 300/304 = 99% | ||
| (97% - 99%)* | 385/390 = 99% | ||
| (97% - 99%)* | |||
| PPX | 145/146 > 99% | ||
| (96% - 99%)* | 304/304 > 99% | ||
| (99% - 99%)** | 449/450 > 99% | ||
| (99% - 99%)* | |||
| TCA | 32/32 > 99% | ||
| (89% - 99%)** | 316/338 = 93% | ||
| (90% - 96%)* | 348/370 = 94% | ||
| (91% - 96%)* |
- Denotes 95% confidence interval.
** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.
Conclusion:
Clinical study results demonstrate the substantial equivalency between the ACON TRIfect" Drug Screen Test Device and the ACON Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants single tests, which have already being cleared by FDA and marketed in the United States. It is also demonstrated that these tests are safe and effective in detecting Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants at the following cut-off concentrations: Amphetamine 1,000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300 ng/mL, Cocaine 300 ng/mL, Marijuana 50 ng/mL, Methylenedioxymethamphetamine 500 ng/mL, Opiates 300 ng/mL, Oxycodone 100 ng/mL, Phencyclidine 25 ng/mL, Propoxyphene 300 ng/mL and Tricyclic Antidepressants 1,000 ng/mL. The physician's office laboratory POL study demonstrated that these tests are also suitable for use by professionals at point-of-care site.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 9 2004
Edward Tung, Ph.D Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
Re: K041743
Ro41745
Trade/Device Name: ACON TRI-fect Drug Screen Test Device Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class: Class II
Product Code: DKZ, DIS JXM DIO, LDJ, LAF, DJG, LCM, JXN, LFG Dated: June 25, 2004 Received: June 28, 2004
Dear Dr. Tung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bottom 310(x) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regists of the Medical Device Amendments, or to conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices may nave been require approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do not require to the general controls provisions of the Act. The r ou may, dicrefore, mains of the Act include requirements for annual registration, listing of general controls profits wing 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), if your device is blussified (600 additional controls. Existing major regulations affecting your device it may be subject to bach additions (CFR), Parts 800 to 895. In addition, FDA can oc found in Ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least of advised that I Dris issumes to the vice complies with other requirements of the Act that I DA has Inade a are regulations administered by other Federal agencies. You must or any I caeral statutes and regarantents, including, but not limited to: registration and listing (21 comply with an the Ace 5 requirements 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Jean M. Cooper US, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K041743
Device Name: ACON TRI-fect Drug Screen Test Device
Indications For Use:
The ACON TRI-fect™ Drug Screen Test Device is a rapid chromatographic ime AOON for the qualitative and simultaneous detection of Amphetamine, ininunoassay 101 (no qualicatio Datonatos, DonLoanaLopmov, Iidine, Propoxyphene and Tricyclic Antidepressants in The designated cut-off concentrations for these drugs are as follows: urine. unne: 1,000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300 ng/mL, Amplietanine - 1,000 hg/mL, Barbiantes ethylenedioxymethamphetamine 500 ng/mL, Opiates 300 ng/mL, Oxycodone 100 ng/mL, Phencyclidine 25 ng/mL, Propoxyphene 300 Oplatos ooo ng/mL, Oxycoepressants 1,000 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
This assay 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 spectrometry (GC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of Onlinour ocholderly when preliminary positive results are used.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alberto Sertz
Division Sign-Off
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) _______________________________________________________________________________________________________________________________________________________________________