(59 days)
There are no reference devices mentioned in the provided text.
No
The device description and performance studies indicate a simple lateral flow immunoassay that provides a visual qualitative result, with no mention of computational analysis, image processing, or AI/ML terms.
No
The device is a diagnostic tool used to detect Benzodiazepines in urine, not to treat a medical condition.
Yes
The device qualitatively detects Benzodiazepines in human urine, which is used for screening purposes to identify the presence of a substance in the body, making it a diagnostic device.
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 strips/devices. It also mentions a "colored-line" appearing on the device.
Based on the provided information, 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 Benzodiazepines in human urine." This involves testing a biological sample (urine) outside of the body to gain information about a person's health status (presence of benzodiazepines).
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes "antigen-antibody immunochemistry" to detect substances in a "urine sample." This is a classic description of an in vitro diagnostic test.
- Performance Studies: The performance studies involve testing clinical urine specimens and comparing the results to a predicate device and a reference method (GC/MS). This type of evaluation is standard for IVD devices to demonstrate their accuracy and reliability.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzodiazepines in human urine at a cut-off concentration of 300 ng/mL set relative to oxazepam, a major metabolite of benzodiazepines. They are intended for healthcare professionals including professionals at point of care sites.
Product codes
JXM
Device Description
The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Benzodiazepines in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Benzodiazepines in urine at a cut-off concentration of 300 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 Benzodiazepines at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will 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
A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with benzodiazepine concentrations at -25% cut-off to +25% cut-off range. This evaluation compared the test results between ACON® BZO One Step Benzodiazepines Test Strip and Test Device with LifeSign Status DSTM BZO One-Step Benzodiazepines Test; as well as against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Evaluation, Comparison Study
Sample Size: 300 clinical urine specimens
Key Results:
- ACON BZO One Step Benzodiazepines Test Strip versus the LifeSign Status DSTM BZO One- Step Benzodiazepines Test:
- Positive Agreement: 131 / 145 = 90% (84% - 95%*)
- Negative Agreement: 149 / 153 = 97% (93% - 99%*)
- Overall Agreement: 280 / 298 = 94% (91% - 96%*)
-
- 95% Confidence Intervals
- ACON BZO One Step Benzodiazepines Test Device versus the LifeSign Status DS™ BZO One-Step Benzodiazenines Test:
- Positive Agreement: 130 / 144 = 90% {84% - 94%* }
- Negative Agreement: 149 / 154 = 97% (92% - 99%*)
- Overall Agreement: 279 / 298 = 94% (90% -96%*)
-
- 95% Confidence Intervals
- ACON BZO One Step Benzodiazepines Test Strip versus GC/MS at the cutoff of 300 ng/ml:
- Positive agreement with GC/MS: 131 / 135 = 97% (92% - 99%*)
- Negative agreement with GC/MS: 157 / 165 = 95% (91% - 98%*)
- Total agreement with GC/MS: 288 / 300 = 96% (93% - 98%*)
-
- 95% confidence intervals
- ACON BZO One-Step Benzodiazepines Test Device versus GC/MS at the cutoff of 300 ng/ml.
- Positive agreement with GC/MS: 130 / 135 = 96% (92% - 98%*)
- Negative agreement with GC/MS: 159 / 165 = 96% (92% - 99%*)
- Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)
-
- 95% confidence intervals
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement, Negative Agreement, Overall Agreement
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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 1 7 2001
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 K012300
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date:
July 16, 2001
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® BZO One Step Benzodiazepines Test Strip
ACON® BZO One Step Benzodiazepines Test Device
Common Name:
Immunochromatographic test for the qualitative detection of Benzodiazepines in urine
Device Classification:
The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are similar to other FDA-cleared devices for the qualitative detection of Benzodiazepines in urine specimens. These tests are used to provide a preliminary analytical result. (21 CFR 862.3170) Benzodiazepines test systems have been classified as Class II devices with moderate complexity.
Classification Name:
Benzodiazepines test system
1
Intended Use:
The ACON® BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzodiazepines in urine at a cut-off concentration of 300 ng/mL set relative to Oxazepam. They are intended for healthcare professionals including professionals at point of care sites.
Description:
The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Benzodiazepines in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Benzodiazepines in urine at a cut-off concentration of 300 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 Benzodiazepines at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred,
Predicate Device:
LifeSign Status DSTM BZO One-Step Benzodiazepines Test
510(k) Number: K991079
Comparison to a Predicate Device:
A comparison of the features of the ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device versus the LifeSign Status DSTM BZO One-Step Benzodiazepines Test is shown below:
- . Both tests are assays intended for the qualitative detection of Benzodiazepines 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 Benzodiazepines with a visual, qualitative end result.
- 8 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 Benzodiazepines concentration of 300 ng/mL. .
2
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with benzodiazepine concentrations at -25% cut-off to +25% cut-off range. This evaluation compared the test results between ACON® BZO One Step Benzodiazepines Test Strip and Test Device with LifeSign Status DSTM BZO One-Step Benzodiazepines Test; as well as against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:
ACON BZO One Step Benzodiazepines Test Strip versus the LifeSign Status DSTM BZO One- Step Benzodiazepines Test:
Positive Agreement: 131 / 145 = 90% (84% - 95%) Negative Agreement: 149 / 153 = 97% (93% - 99%") Overall Agreement: 280 / 298 = 94% (91% - 96%) * 95% Confidence Intervals
ACON BZO One Step Benzodiazepines Test Device versus the LifeSign Status DS™ BZO One-Step Benzodiazenines Test:
Positive Agreement: 130 / 144 = 90% {84% - 94%* } Negative Agreement: 149 / 154 = 97% (92% - 99%) Overall Agreement: 279 / 298 = 94% (90% -96%) * 95% Confidence Intervals
ACON BZO One Step Benzodiazepines Test Strip versus GC/MS at the cutoff of 300 ng/ml:
Positive agreement with GC/MS: 131 / 135 = 97% (92% - 99%) Negative agreement with GC/MS: 157 / 165 = 95% (91% - 98%) Total agreement with GC/MS: 288 / 300 = 96% (93% - 98%*) * 95% confidence intervals
ACON BZO One-Step Benzodiazepines Test Device versus GC/MS at the cutoff of 300 ng/ml.
Positive agreement with GC/MS: 130 / 135 = 96% (92% - 98%) Negative agreement with GC/MS: 159 / 165 = 96% (92% - 99%) Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*) * 95% confidence intervals
Conclusion:
These clinical studies demonstrate the substantial equivalency between the ACON BZO One Step Benzodiazepines Test Strip, ACON BZO One Step Benzodiazepines Test Device and the LifeSign Status DSTM BZO One-Step Benzodiazepines Test, which has already being marketed in the United States. It is also demonstrated that these tests are safe and effective in detecting Benzodiazepines at a concentration of 300 ng/mL. The POL study demonstrated that these tests are suitable for professional and point-of-care use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract shapes that resemble human profiles and waves, representing the department's focus on health and human well-being. The seal is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 7 2001
Edward Tung, Ph.D. Director of Regulatory Affair ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, CA 92121
K012300 Re:
K012500
Trade/Device Name: ACON BZO One Step Benzodiazepines Test Strip ACON BZO One Step Benzodiazepines Test Device Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: July 16, 2001 Received: July 20, 2001
Dear Dr. Tung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalling is the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to comments problem to May 20, 1976, are excordance with the provisions of the Federal Food, Drug, devices may been recalismed in assess asproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the rice, 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 If your device is classified (socure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA wo inay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous cevents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I DT 3 lossantes of our device complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any I ederal statutes and regulations and limited to: registration and listing (21 compry with an the rice srequirements, and manufacturing practice requirements as set CITY at 807), adomig (21 OFR Part 820), and if applicable, the electronic form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
5
10. INDICATIONS FOR USE
K012300 510(k) Number:
Device Name: ACON® BZO One Step Benzodiazepines Test Strip
ACON® BZO One Step Benzodiazepines Test Device
Indications for Use:
The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzodiazepines in human urine at a cut-off concentration of 300 ng/mL set relative to oxazepam, a major metabolite of benzodiazepines. 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
Kesia Alexander for Joan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012300