(176 days)
Not Found
No
The device description and performance studies indicate a standard immunoassay technology, with no mention of AI or ML.
No.
This device is an immunoassay for the qualitative detection of drugs in human urine, providing preliminary analytical test results for diagnostic purposes, not for treating any condition.
Yes
This device is designed for the qualitative and simultaneous detection of drugs in human urine, providing preliminary analytical test results for substances of abuse. This function aligns with the definition of a diagnostic device, which is used to detect diseases or conditions.
No
The device description explicitly states it is a "colloidal gold based chromatographic immunoassay," which is a physical test kit, not software.
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 one to ten of the following drugs... in human urine." This is a diagnostic test performed on a biological sample (urine) in vitro (outside the body).
- Device Description: The description confirms it's a "chromatographic immunoassay for the rapid, qualitative detection of [various drugs] in human urine." This further supports its use as an in vitro test.
- Performance Studies: The document describes performance studies using "clinical specimens," which are biological samples used for diagnostic testing.
- Predicate Devices: The listed predicate devices are also IVDs (ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device).
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Applied DNA Technologies ACCUSTEP DOA Screen Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to ten of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration |
|---|---|---|---|
| Amphetamine | AMP | Amphetamine | 1000 ng/ml |
| Barbiturate | BAR | Secobarbital | 300 ng/ml |
| Benzodiazepines | BZO | Oxazepam | 300 ng/ml |
| Cocaine | COC | Benzoylecgonine | 300 ng/ml |
| Marijuana | THC | 11-nor- $\Delta$9 -THC9-COOH | 50 ng/ml |
| Methamphetamine | MET | Methamphetamine | 1000 ng/ml |
| Methadone | MTD | Methadone | 300 ng/ml |
| Morphine | MOR | Morphine | 2000 ng/ml |
| Phencyclidine | PCP | Phencyclidine | 25 ng/ml |
| Nortriptyline | NOR | Nortriptyline | 1000 ng/ml |
These test kits are intended for health care professional use only.
This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, DIO, LDJ, DNK, DJC, DJR, LCM, LFG
Device Description
One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana. Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline, a Tricyclic Antidepressant, in human urine.
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
health care professional use only.
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
The product performance characteristics of ACCUSTEP DOA Screen Panels were evaluated in the blind-labeled clinical specimen correlation study. The study involved GC/MS confirmed clinical urine specimens.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance characteristics of ACCUSTEP DOA Screen Panels were evaluated in the blind-labeled clinical specimen correlation study. The results demonstrate the ACCUSTEP DOA Screen Panels to be substantially equivalent to the performance characteristics of GC/MS methodology as well as ACON's One Step Multi-Drug Screen Test Cards, using clinical specimens, produced a >92% correlation when compared to the GC/MS methodology.
ACCUSTEP DOA Screening Panels vs. GC/MS Analysis:
Samples with drug concentration above the cutoff level were considered presumptive positive and concentration below the cutoff were considered negative.
| Test | Positive Agreement | Negative Agreement | Overall Agreement |
|---|---|---|---|
| AMP | 46/48 = 95.8% | 55/55 = 100% | 101/103 = 98.1% |
| BAR | 45/46 = 97.8% | 51/52 = 98.1% | 96/98 = 98.0% |
| BZO | 41/43 = 95.3% | 52/56 = 92.9% | 93/99 = 93.9% |
| COC | 55/56 = 98.2% | 53/54 = 98.1% | 108/110 = 98.2% |
| MET | 61/63 = 96.8% | 52/52 = 100% | 113/115 = 98.3% |
| MOR | 40/41 = 97.6% | 63/64 = 98.4% | 103/105 = 98.1% |
| MTD | 49/51 = 96.1% | 54/54 = 100% | 103/105 = 98.1% |
| PCP | 45/46 = 97.8% | 48/48 = 100% | 93/94 = 98.9% |
| NOR | 35/38 = 92.1% | 57/57 = 100% | 92/95 = 96.8% |
| THC | 60/62 = 96.8% | 59/60 = 98.3% | 119/122 = 97.5% |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device K023946, ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device K020313
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
The Assigned 510(k) number is K061005
Name of Submitter:
Applied DNA Technologies Inc. 3337 Fosca Street Carlsbad, CA 92009 Tel .: (714) 624-2347 Fax: (949) 348-2372
Contact Person:
Feng-Yu Lee
Identification / Product Name:
ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels
Description:
One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana. Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline, a Tricyclic Antidepressant, in human urine.
Intended Use:
The Applied DNA Technologies ACCUSTEP DOA Screen Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to ten of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct callbrator for these drugs are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration |
|---|---|---|---|
| Amphetamine | AMP | Amphetamine | 1000 ng/ml |
| Barbiturate | BAR | Secobarbital | 300 ng/ml |
| Benzodiazepines | BZO | Oxazepam | 300 ng/ml |
| Cocaine | COC | Benzoylecgonine | 300 ng/ml |
| Marijuana | THC | 11-nor- $Δ9$ -THC9-COOH | 50 ng/ml |
| Methamphetamine | MET | Methamphetamine | 1000 ng/ml |
| Methadone | MTD | Methadone | 300 ng/ml |
| Morphine | MOR | Morphine | 2000 ng/ml |
| Phencyclidine | PCP | Phencyclidine | 25 ng/ml |
| Nortriptyline | NOR | Nortriptyline | 1000 ng/ml |
These test kits are intended for health care professional use only.
This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
OCT - 4 2006
1
Predicate Kit:
Predicate KIT:
ACON One Step Multi-Drug Screen Test Card are used as predicate device for ACCUSTEP Single ACON One Step Multi-Drug Goreen Post Sare are are are are with the GC/MS confirmed clinical urine specimens.
| 510(k) number for these predicate devices are: | |
|---|---|
| ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device | K023946 |
| ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device | K020313 |
Performance:
reflorinance characteristics of ACCUSTEP DOA Screen Panels were evaluated in the The product performance characteriand in the blind-labeled clinical specimen correlation study. The results of these studies demonstrate the ACCUSTEP DOA Screen Panels to be substantially equivalent to the performance characteristics of GC/MS methodology as well as ACON's One Step equivalent to the performance entines, using clinical specimens, produced a >92% correlation when compared to the GC/MS methodology.
ACCUSTEP DOA Screening Panels vs. GC/MS Analysis
Samples with drug concentration above the cutoff level were considered presumptive positive and concentration below the cutoff were considered negative.
| Test | Positive
Agreement | Negative
Agreement | Overall
Agreement |
|------|-----------------------|-----------------------|----------------------|
| AMP | 46/48 = 95.8% | 55/55 = 100% | 101/103 = 98.1% |
| BAR | 45/46 = 97.8% | 51/52 = 98.1% | 96/98 = 98.0% |
| BZO | 41/43 = 95.3% | 52/56 = 92.9% | 93/99 = 93.9% |
| COC | 55/56 = 98.2% | 53/54 = 98.1% | 108/110 = 98.2% |
| MET | 61/63 = 96.8% | 52/52 = 100% | 113/115 = 98.3% |
| MOR | 40/41 = 97.6% | 63/64 = 98.4% | 103/105 = 98.1% |
| MTD | 49/51 = 96.1% | 54/54 = 100% | 103/105 = 98.1% |
| PCP | 45/46 = 97.8% | 48/48 = 100% | 93/94 = 98.9% |
| NOR | 35/38 = 92.1% | 57/57 = 100% | 92/95 = 96.8% |
| THC | 60/62 = 96.8% | 59/60 = 98.3% | 119/122 = 97.5% |
Conclusion:
Convilles of Accuracy, Sensitivity, Precision, Specificity and Interference studies demonstrate the substantial equivalency between the ACCUSTEP DOA Screen Panels and the ACON One Step Multi-Drug Screen Test Card. It is also demonstrated that ACCUSTEP DOA Screen Panels are safe and effective in detecting Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methamphetamine, Methadone, Morphine, Phencyclidine, and Nortriptyline, a Tricyclic Antidepressant, in human urine specimen.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a stylized drawing of a bird in flight. The bird is depicted with three parallel lines forming its body and wings, giving it a sense of movement and dynamism. The lines are thick and bold, creating a strong visual impact against the white background. The overall design is simple yet elegant, capturing the essence of a bird soaring through the air.
Public Hoa to Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Feng-Yu Lee Vice President of Operation Applied DNA Technologies Inc. 26251 Verona Place Mission Viejo, CA 92692
OCT = 4 2006
Re: K061005
Trade/Device Name: ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, DIO, LDJ, DNK, DJC, DJR, LCM, LFG Dated: August 4, 2006 Received: August 8, 2006
Dear Ms. Lee:
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 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, Trug, 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, insting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, noand 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 be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K061005
Device Name: ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels
Indications For Use:
Applied DNA Technologies ACCUSTEP DOA Panels are rapid chromatographic The immunoassays for the qualitative and simultaneous detection of one to ten of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration |
|---|---|---|---|
| Amphetamine | AMP | Amphetamine | 1000 ng/ml |
| Barbiturate | BAR | Secobarbital | 300 ng/ml |
| Benzodiazepines | BZO | Oxazepam | 300 ng/ml |
| Cocaine | COC | Benzoylecgonine | 300 ng/ml |
| Marijuana | THC | 11-nor- $\Delta^9$ -THC9-COOH | 50 ng/ml |
| Methamphetamine | MET | Methamphetamine | 1000 ng/ml |
| Methadone | MTD | Methadone | 300 ng/ml |
| Morphine | MOR | Morphine | 2000 ng/ml |
| Phencyclidine | PCP | Phencyclidine | 25 ng/ml |
| Nortriptyline | NOR | Nortriptyline | 1000 ng/ml |
These test kits are intended for health care professional use only.
This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
vision Sign-Oi
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Office of In Vitro Diagnostic Device Evaluation and S
5106(k) K061005