(59 days)
The ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of Barbiturates in urine at a cutoff concentration of 300 ng/mL. 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. They are intended for healthcare professionals including professionals at point-of-care sites.
The ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Barbiturates in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Barbiturates and its metabolite in urine at a cutoff 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 Barbiturates at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a coloredline should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: ACON BAR II One Step Barbiturates Test Strip & Device
The information provided describes a qualitative immunoassay for the detection of Barbiturates in urine. The primary acceptance criteria appear to be substantial equivalence to an existing FDA-cleared device and satisfactory agreement with Gas Chromatography/Mass Spectrometry (GC/MS) analysis, particularly around the 300 ng/mL cutoff concentration.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria prior to presenting the results. However, based on the discussion of "substantial equivalency" and the reported data, the implicit acceptance criteria are high levels of agreement with both a predicate device and the gold standard (GC/MS).
| Acceptance Criteria (Implicit) | Reported Device Performance (ACON BAR II One Step Barbiturates Test Strip / Device) |
|---|---|
| High Positive Agreement with FDA-cleared Barbiturates Test | > 99% (120/120) with 95% CI (97% - 100%) |
| High Negative Agreement with FDA-cleared Barbiturates Test | 87% (156/180) with 95% CI (81% - 91%) |
| High Overall Agreement with FDA-cleared Barbiturates Test | 92% (276/300) with 95% CI (88% - 95%) |
| High % Agreement (Positive) with GC/MS (near cutoff) | 99% (141/142) with 95% CI (96% - 99%) |
| High % Agreement (Negative) with GC/MS (near cutoff) | 98% (155/158) with 95% CI (95% - 99%) |
| High Total Agreement with GC/MS | 98.67% (296/300) with 95% CI (97% - 99%) |
| Satisfactory performance by healthcare professionals at POC | 97% (262/270) of cases interpreted correctly by POL staff |
| Comparable POL study results to trained lab technician | 97% (87/90) for trained lab technician |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 300 clinical urine specimens.
- Data Provenance: "Clinical urine specimens" (retrospective, implies real-world samples from a clinical setting). The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is a laboratory analytical method, not directly performed by "experts" in the sense of human readers/interpreters in this context. It's a gold standard objective chemical analysis. Therefore, the concept of "number of experts" and their "qualifications" as human interpreters is not applicable here. GC/MS analysis is typically performed by trained laboratory technicians or chemists.
4. Adjudication Method for the Test Set
The adjudication method described is comparison against GC/MS analysis. There is no mention of an adjudication process among multiple human experts. The ACON BAR II test results were compared directly against the GC/MS results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done in the sense of comparing human readers with and without AI assistance. The study compared the device (a rapid diagnostic test, not an AI) against a predicate device and GC/MS.
There was a "POL Study" (Point-of-Care) that indicated:
- Personnel at different doctor's offices with various educational backgrounds and working experience could perform the tests properly and interpret results correctly in most cases (97%, 262/270).
- These results were comparable to those obtained from a trained lab technician (97%, 87/90).
This study evaluated user performance of the device, not the device's ability to assist human readers in a diagnostic task where the device itself is an AI application.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the primary accuracy evaluations against the predicate device and GC/MS were standalone performance studies of the ACON BAR II tests (Strip and Device). The tests are rapid chromatographic immunoassays that yield a visual result (presence or absence of a colored line). While a human interprets the visual result, the "performance" figures (agreement percentages) are based on the device's output compared to the reference methods, effectively a standalone evaluation of the device's analytical capability.
7. The Type of Ground Truth Used
The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is considered a highly objective and definitive chemical analysis method often referred to as the "gold standard" for drug detection.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or a separate dataset used for the development or training of the device. Given that this is an immunoassay, not a machine learning algorithm, the concept of a "training set" as understood in AI/ML is not directly applicable. These devices are typically developed through iterative chemical and engineering optimization.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, the concept of a "training set" with established ground truth, as defined for AI/ML, does not apply to this immunoassay device. The device's underlying principles are based on antibody-antigen interactions, developed through chemical and biological research and optimization.
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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.
The Assigned 510(k) number is KO50593
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date:
March 7, 2005
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® BAR II One Step Barbiturates Test Strip ACON® BAR II One Step Barbiturates Test Device
Common Name:
Immunochromatographic test for the qualitative detection of Barbiturates in urine.
Regulation Name:
Barbiturates test system.
Product Code:
DIS
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Classification Number:
21.CFR. 862.3150
Device Classification:
The Barbiturates test systems have been classified as Class II devices with moderate complexity. The ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device are similar to another FDA-cleared device for the qualitative detection of Barbiturates 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 BAR II One Step Barbiturates Test Strip and ACON BAR II One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of Barbiturates in urine at a cutoff concentration of 300 ng/mL. 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. They are intended for healthcare professionals including professionals at point-of-care sites.
Description:
The ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Barbiturates in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Barbiturates and its metabolite in urine at a cutoff 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 Barbiturates at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a coloredline should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
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Comparison to a Predicate Device:
A comparison of the features of the ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device versus a FDA-cleared Barbiturates test with 300 ng/mL Barbiturates cutoff is shown below:
- Both tests are assays intended for the qualitative detection of Barbiturates 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 . Barbiturates 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 cutoff Barbiturates concentration of 300 ng/mL. .
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Barbiturates concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between the ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device with a FDA-cleared Barbiturates 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 BAR II One Step Barbiturates Test Strip versus a FDA-cleared BAR Test:
Positive Agreement: 120 / 120 > 99% (97% - 100%) ** Negative Agreement: 156 / 180 = 87% (81% - 91%)* Overall Agreement: 276 / 300 = 92% (88% - 95%)* ** Since the proportion cannot go above 100%, this is really a 97.5% confidence interval.
-
- 95% confidence intervals
ACON BAR II One Step Barbiturates Test Device versus a FDA-cleared BAR Test:
Positive Agreement: 120 / 120 > 99% (97% - 100%) ** Negative Agreement: 156 / 180 = 87% (81% - 91%)* Overall Agreement: 276 / 300 = 92% (88% - 95%)* ** Since the proportion cannot go above 100%, this is really a 97.5% confidence interval. * 95% confidence intervals
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ACON BAR II One Step Barbiturates Test Strip versus data obtained with GC/MS at the cutoff concentration of 300 ng/mL:
| TestResult | Specimen Cutoff Range by GC/MS Data | ||||||
|---|---|---|---|---|---|---|---|
| Negative+ | < -25%Cutoff | -25% toCutoff | Cutoff to+25% | > +25%Cutoff | % Agreement | ||
| ACONBAR IITestStrip | Positive | 0 | 1 | 2 | 9 | 132 | 99% (141/142)(96% - 99%)* |
| Negative | 149 | 0 | 6 | 0 | 1 | 98% (155/158)(95% - 99%)* |
ACON BAR II One Step Barbiturates Test Strip versus GC/MS.
Total agreement with GC/MS: 296/300 = 98.67% (97%- 99%)*
- Denotes 95% confidence interval.
- Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of న్
| ACON BAR II One Step Barbiturates Test Device versus GC/MS. | ||
|---|---|---|
| -- | -- | ------------------------------------------------------------- |
| TestResult | Specimen Cutoff Range by GC/MS Data | ||||||
|---|---|---|---|---|---|---|---|
| Negative+ | < -25%Cutoff | -25% toCutoff | Cutoff to+25% | > +25%Cutoff | % Agreement | ||
| ACONBAR IITestDevice | Positive | 0 | 1 | 2 | 9 | 132 | 99% (141/142)(96% - 99%)* |
| ACONBAR IITestDevice | Negative | 149 | 0 | 6 | 0 | 1 | 98% (155/158)(95% - 99%)* |
Total agreement with GC/MS: 296/300 = 98.67% (97%- 99%)*
- Denotes 95% confidence interval.
† Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of న్.
Performance Characteristics and Other information:
The performance characteristics of the ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates 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.
POL Study Summary:
Test results obtained from three POL study sites indicated that personnel at different doctor's offices with various educational background and working experience could perform the ACON® BAR II One Step Barbiturates tests properly and interpret test results correctly in most cases (97%, 262/270). The POL study results are also comparable to those obtained from a trained lab technician (97%, 87/90).
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Conclusion:
These clinical studies demonstrated substantial equivalency on performance among the ACON BAR II One Step Barbiturates Test Strip, the ACON BAR II One Step Barbiturates Test Device and a FDA-cleared Barbiturates test with the same Barbiturates cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Barbiturates at a concentration of 300 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle. The text is arranged in a circular fashion around the eagle, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 6 2005
Edward Tung, Ph. D. Regulatory Affairs ACON Laboratories 4108 Sorrento Valley Blvd San Diego, CA 92121
Re: K050593
Trade/Device Name: ACON BAR II One Step Barbiturates Test Strip ACON BAR II One Step Barbiturates Test Device Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS Dated: March 7, 2005 Received: March 8, 2005
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 for accession 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 1 ou may 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 r that FDA has made a determination that your device complies with other requirements of the Act that I DA has intact and regulations administered by other Federal agencies. You must or any I vatures 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).
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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,
Jean M. Cooper MS, DUM
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
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INDICATIONS FOR USE 11.
510(k) Number (if known): K0505959
ACON BAR II One Step Barbiturates Test Strip Device Name:
ACON BAR II One Step Barbiturates Test Device
Indications for Use:
The ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step The ACON DAR II One Bep Bail chromatographic immunoassays for the qualitative Barbiturates Test Device are rapia virus at a designated cutoff concentration of 300 ng/mL delection of Darontales for healthcare professionals including professionals at point-of-care sites.
This assay provides only a preliminary analytical test result. A more specific alternate Themical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory methods.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly 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)
Albert Satz
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluntion and Safety
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§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).