(153 days)
Not Found
Not Found
No
The device description clearly states it is a lateral flow immunochromatographic assay that can be performed without an instrument, relying on visual interpretation of colored lines. There is no mention of any computational analysis, image processing, or AI/ML terms.
No
The device is a rapid immunoassay for the qualitative detection of Benzoylecgonine in urine, intended for diagnostic screening rather than treating or preventing a disease or condition.
Yes
The ACON COC-150 One Step Cocaine Test Strip and Device are described as "rapid chromatographic immunoassays for the qualitative detection of Benzoylecgonine in urine," and their performance is evaluated based on sensitivity and specificity metrics, which are typical for diagnostic tests used to identify the presence of a specific substance in a biological sample.
No
The device description clearly states it is a "rapid chromatographic immunoassay" and a "competitive binding, lateral flow immunochromatographic assay," which are physical test strips/devices, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of Benzoylecgonine in urine." This involves testing a sample taken from the human body (urine) outside of the body to provide information about a physiological state (presence of a drug metabolite).
- Device Description: The description details a "rapid chromatographic immunoassay" and "competitive binding, lateral flow immunochromatographic assays" that utilize "antigen-antibody immunochemistry" to detect a substance in a urine sample. These are all characteristics of in vitro diagnostic tests.
- Sample Type: The device analyzes a "urine sample," which is a biological specimen.
- Purpose: The purpose is to detect the presence of Benzoylecgonine, a metabolite of cocaine, which is used to diagnose or screen for drug use.
The definition of an In Vitro Diagnostic (IVD) device generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While drug screening isn't always strictly for diagnosing a disease, it falls under the broader scope of providing information about a person's health status or condition.
Therefore, based on the provided information, the ACON COC-150 One Step Cocaine Test Strip and Device clearly fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACON® COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzoylecgonine in urine at a cutoff concentration of 150 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites. The ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzoylecgonine levels in urine at a designated cutoff concentration of 150 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
Product codes (comma separated list FDA assigned to the subject device)
DIO
Device Description
The ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Benzoylecgonine in a urine sample. The test is based on the principle of antigenantibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of cocaine and its metabolite (Benzoylecgonine) in urine at a cutoff concentration of 150 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Benzoylecgonine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
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 professionals including professionals at 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy
A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Benzoylecgonine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON® COC-150 One Step Cocaine Test Strip and ACON® COC-150 One Step Cocaine Test Device with a FDA-cleared cocaine test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis.
ACON COC-150 One Step Cocaine Test Strip versus FDA-cleared Cocaine Test:
Positive Agreement: 141 / 141 = 100% (97.4% - 100%)
Negative Agreement: 159 / 159 = 100% (97.7% - 100%)
Overall Agreement: 300/300 = 100% (98.8% - 100%*)
ACON COC-150 One Step Cocaine Test Device versus FDA-cleared Cocaine Test:
Positive Agreement: 141 / 141 = 100% (97.4% - 100%)
Negative Agreement: 159 / 159 = 100% (97.7% - 100%)
Overall Agreement: 300/300 = 100% (98.8% - 100%*)
ACON COC-150 One Step Cocaine Test Strip versus data obtained with GC/MS at the cutoff concentration of 150 ng/mL:
For "Positive" ACON COC-150 Test Strip:
0 clinical urine specimens in "Negative" range
0 clinical urine specimens in "-25% Cutoff to Cutoff" range
8 clinical urine specimens in "Cutoff to +25% Cutoff" range
133 clinical urine specimens in "> +25% Cutoff" range
% Agreement with GC/MS: 98.6% (95.0% - 99.8%)**
For "Negative" ACON COC-150 Test Strip:
150 clinical urine specimens in "Negative" range
7 clinical urine specimens in "-25% Cutoff to Cutoff" range
0 clinical urine specimens in "Cutoff to +25% Cutoff" range
2 clinical urine specimens in "> +25% Cutoff" range
% Agreement with GC/MS: 98.7% (95.5% -99.6%)**
ACON COC-150 One Step Cocaine Test Device versus data obtained with GC/MS at the cutoff concentration of 150 ng/mL:
For "Positive" ACON COC-150 Test Device:
0 clinical urine specimens in "Negative" range
0 clinical urine specimens in "-25% Cutoff to Cutoff" range
8 clinical urine specimens in "Cutoff to +25% Cutoff" range
133 clinical urine specimens in "> +25% Cutoff" range
% Agreement with GC/MS: 98.6% (95.0% - 99.8%)**
For "Negative" ACON COC-150 Test Device:
150 clinical urine specimens in "Negative" range
7 clinical urine specimens in "-25% Cutoff to Cutoff" range
0 clinical urine specimens in "Cutoff to +25% Cutoff" range
2 clinical urine specimens in "> +25% Cutoff" range
% Agreement with GC/MS: 98.7% (95.5% - 99.6%)**
Performance Characteristics and Other information:
The performance characteristics of ACON COC-150 One Step Cocaine Test Strip, ACON COC-150 One Step Cocaine Test Device were verified by analytical sensitivity study, specificity and cross reactivity study, interference studies, precision study, read time flex study, temperature flex study, specimen storage and stability study. Study results indicate that these test devices are robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in their package inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement, Negative Agreement, Overall Agreement, % Agreement with GC/MS.
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.
Not Found
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
§ 862.3250 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).
0
page 1 of 4
FEB 1 7 2004
510(k) SUMMARY 8.
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
-032903 The Assigned 510(k) number is
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel .: 858-535-2030 Fax: 858-535-2038
Date:
September 12, 2003
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® COC-150 One Step Cocaine Test Strip ACON® COC-150 One Step Cocaine Test Device
Common Name:
Immunochromatographic test for the qualitative detection of Benzoylecgonine in urine.
Classification Name:
Cocaine test system.
Device Classification:
1
page 2 of 4
The Cocaine test systems have been classified as Class II devices with moderate complexity. The ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are similar to other FDA-cleared devices for the qualitative detection of Benzoylecgonine, a major cocaine metabolite, in urine specimens. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis.
Intended Use:
The ACON® COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzoylecgonine in urine at a cutoff concentration of 150 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
Description:
The ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Benzoylecgonine in a urine sample. The test is based on the principle of antigenantibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of cocaine and its metabolite (Benzoylecgonine) in urine at a cutoff concentration of 150 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Benzoylecgonine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Comparison to a Predicate Device:
A comparison of the features of the ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device versus a FDA-cleared cocaine test with 150 ng/mL benzoylecgonine cutoff is shown below:
- . Both tests are assays intended for the qualitative detection of Benzovlecgonine 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 of . Benzoylecgonine with a visual, qualitative end result.
- . Both tests utilize the same basic immunoassay principles that rely on antigen/ antibody interactions to indicate a positive or negative result.
- Both tests have a cut-off Benzoylecgonine concentration of 150 ng/mL. .
2
page 3 of 4
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Benzoylecgonine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON® COC-150 One Step Cocaine Test Strip and ACON® COC-150 One Step Cocaine Test Device with a FDA-cleared cocaine test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. These comparisons of data yielded the following results:
ACON COC-150 One Step Cocaine Test Strip versus FDA-cleared Cocaine Test:
Positive Agreement: 141 / 141 = 100% (97.4% - 100%) Negative Agreement: 159 / 159 = 100% (97.7% - 100%) Overall Agreement: 300/300 = 100% (98.8% - 100%*)
- Since the proportion (%) cannot go above 100%, this is really a 97.5% Confidence interval.
ACON COC-150 One Step Cocaine Test Device versus FDA-cleared Cocaine Test:
Positive Agreement: 141 / 141 = 100% (97.4% - 100%) Negative Agreement: 159 / 159 = 100% (97.7% - 100%) Overall Agreement: 300/300 = 100% (98.8% - 100%*)
- Since the proportion (%) cannot go above 100%, this is really a 97.5% Confidence interval.
ACON COC-150 One Step Cocaine Test Strip versus data obtained with GC/MS at the cutoff concentration of 150 ng/mL:
| Benzoylecgonine Conc.
vs. Cutoff | | Negative | -25%
Cutoff to
Cutoff | Cutoff to
+25% Cutoff | > +25%
Cutoff | % Agreement with
GC/MS |
|-------------------------------------|----------|----------|-----------------------------|--------------------------|------------------|----------------------------|
| ACON
COC-150
Test Strip | Positive | 0 | 0 | 8 | 133 | 98.6%
(95.0% - 99.8%)** |
| | Negative | 150 | 7 | 0 | 2 | 98.7%
(95.5% -99.6%)** |
- Denotes 95% Confidence Interval.
3
page 4 of 4
ACON COC-150 One Step Cocaine Test Strip versus data obtained with GC/MS at the cutoff concentration of 150 ng/mL
| Benzoylecgonine Conc. vs. Cutoff | Negative | -25% Cutoff to Cutoff | Cutoff to +25% Cutoff | > +25% Cutoff | % Agreement with GC/MS | |
|---|---|---|---|---|---|---|
| ACON COC-150 | ||||||
| Test Device | Positive | 0 | 0 | 8 | 133 | 98.6% |
| (95.0% - 99.8%)** | ||||||
| ACON COC-150 | ||||||
| Test Device | Negative | 150 | 7 | 0 | 2 | 98.7% |
| (95.5% - 99.6%)** |
- Denotes 95% Confidence Interval
Performance Characteristics and Other information:
The performance characteristics of ACON COC-150 One Step Cocaine Test Strip, ACON COC-150 One Step Cocaine Test Device were verified by analytical sensitivity study, specificity and cross reactivity study, interference studies, precision study, read time flex study, temperature flex study, specimen storage and stability study. Study results indicate that these test devices are robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in their package inserts.
Conclusion:
These clinical studies demonstrated substantial equivalency on performance between the ACON COC-150 One Step Cocaine Test Strip, ACON COC-150 One Step Cocaine Test Device and a FDA-cleared cocaine test with the same cocaine cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Benzoylecgonine at a concentration of 150 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three arms or lines extending upwards, representing health and well-being. The graphic is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)", which is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MO 20850
FEB 1 7 2004
Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
K032903 Re:
Trade/Device Name: ACON® COC-150 One Step Cocaine Test Strip ACON® COC-150 One Step Cocaine Test Device Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: November 25, 2003 Received: January 6, 2004
Dear Dr. Tung:
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, Drug, 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, 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 (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).
5
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, MS, 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
6
11. INDICATIONS FOR USE
510(k) Number:
ACON® COC-150 One Step Cocaine Test Strip Device Name: ACON® COC-150 One Step Cocaine Test Device
Indications for Use:
The ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzoylecgonine levels in urine at a designated cutoff concentration of 150 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
(Per 21 CFR 801.109)
Or
Over-The-Counter Use
Haleh Zandi
Revision Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032923
વર્સ