ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE

K012824 · ACON Laboratories, Inc. · DIS · Nov 9, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012824
• Device Name: ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Nov 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

The ACON® BAR One Step Barbiturates Test Strip and ACON BAR One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of barbiturates in urine at a cut-off concentration of 300 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites.

Device Story

Rapid chromatographic immunoassay; lateral flow; competitive binding principle. Detects barbiturates in human urine at 300 ng/mL cut-off. Input: urine specimen. Operation: antigen-antibody immunochemistry; drug-positive sample prevents colored-line formation in test region; negative sample or concentration below cut-off generates colored-line. Procedural control line confirms proper volume and wicking. Used at point-of-care sites by healthcare professionals. No instrumentation required. Provides preliminary analytical result; requires confirmation by alternative chemical method (e.g., GC/MS). Benefits: rapid screening for barbiturate presence.

Clinical Evidence

Clinical evaluation of 292 urine specimens. Compared ACON test strips/devices against MCC Instant Screen Card BAR Test and GC/MS. ACON vs. MCC: 99% overall agreement. ACON vs. GC/MS: 95% total agreement (92% positive agreement, 98% negative agreement) at 300 ng/mL cut-off. Study included 10% of samples near cut-off (-25% to +25%).

Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding format. Visual qualitative readout. No external energy source or instrumentation required. Standalone test strip or device format.

Indications for Use

Indicated for qualitative detection of barbiturates in human urine at a 300 ng/mL secobarbital cut-off concentration. Intended for use by healthcare professionals at point-of-care sites.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• MCC Instant Screen Card BAR Test (K002337)

Submission Summary (Full Text)

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# NOV 0 9 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 K012824.

### Submitter:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: [phone] Fax: [phone]

### Date:

August 17, 2001

#### Contact Person:

Edward Tung, Ph.D.

### Product Names:

ACON® BAR One Step Barbiturates Test Strip

ACON® BAR One Step Barbiturates Test Device

### Common Name:

Immunochromatographic test for the qualitative detection of barbiturates in urine

## Device Classification:

The ACON BAR One Step Barbiturates Test Strip and ACON BAR One Step Barbiturates Test Device are similar to other FDA-cleared devices for the qualitative detection of barbiturates in urine specimens. These tests are used to provide a preliminary analytical result (21 CFR 862.3150). This type of barbiturates test systems (Product Code: DIS) have been classified as Class II devices with moderate complexity.

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#### Classification Name:

Barbiturates test system

#### Intended Use:

The ACON® BAR One Step Barbiturates Test Strip and ACON BAR One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of barbiturates in urine at a cut-off concentration of 300 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites.

### Description:

The ACON BAR One Step Barbiturates Test Strip and ACON BAR One Step Device are competitive binding. lateral flow Test Barbiturates immunochromatographic assays for the qualitative screening of barbiturates in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of barbiturates in urine specimens at a designated 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 barbiturates 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:

MCC Instant Screen Card BAR Test

Distributed by Medical & Clinical Consortium (MCC), City of Industry, CA 91746-2048

510(k) Number: K002337

### Comparison to a Predicate Device:

A comparison of the features of the ACON BAR One Step Barbiturates Test Strip and ACON BAR One Step Barbiturates Test Device versus the MCC Instant Screen Card BAR Test is shown below:

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- 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 cut-off concentration of 300 ng/mL for secobarbital. .

# Safety and Effectiveness Data:

# Accuracy

A clinical evaluation was conducted using 292 clinical urine specimens including 10% of the samples with barbiturate concentrations at -25% cut-off to +25% cut-off range. This evaluation compared the test results between ACON® BAR One Step Barbiturates Test Strip and Test Device with MCC Instant Screen Card BAR 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 BAR One Step Barbiturates Test Strip versus MCC Instant Screen Card BAR Test:

Positive Agreement: 126 / 126 = 100% (97% -100%*) Negative Agreement: 165 / 166 = 99% (97% -100%*) Overall Agreement: 291 / 292 = 99% (98 % -100%*)

* 95% Confidence Intervals

ACON BAR One Step Barbiturates Test Device versus the MCC Instant Screen Card BAR Test:

> Positive Agreement: 126 / 126 = 100% (97% -100%*) Negative Agreement: 165 / 166 = 99% (97% -100%*) Overall Agreement: 291 / 292 = 99% (98 % -100%*)

> > * 95% Confidence Intervals

ACON BAR One Step Barbiturates Test Strip versus GC/MS at the secobarbital cut-off concentration of 300 ng/ml:

> Positive agreement with GC/MS: 122 / 132 = 92% (86% -96%*) Negative agreement with GC/MS: 156 / 160 = 98% (94% -99%*) Total agreement with GC/MS: 278 / 292 = 95% (92% -97%*)

> > * 95% confidence intervals

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ACON BAR One-Step Barbiturates Test Device versus GC/MS at the secobarbital cut-off concentration of 300 ng/ml:

> Positive agreement with GC/MS: 122 / 132 = 92% (86% -96%*) Negative agreement with GC/MS: 156 / 160 = 98% (94% -99%*) Total agreement with GC/MS: 278 / 292 = 95% (92% -97%*)

> > * 95% confidence intervals

#### Conclusion:

These clinical studies demonstrate the substantial equivalency between the ACON BAR One Step Barbiturates Test Strip, ACON BAR One Step Barbiturates Test Device and the MCC Instant Screen Card BAR Test, which has already being marketed in the United States. It is also demonstrated in the performance studies that the ACON BAR One Step Barbiturates Test Strip, ACON BAR One Step Barbiturates Test Device are safe and effective in qualitatively detecting barbiturates in urine specimens at a secobarbital cut-off concentration of 300 ng/mL. The POL study demonstrated that these tests are suitable for use by healthcare professionals including professionals at point-of-care sites.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 0 9 2001

Edward Tung. Ph.D. Director of Regulatory Affair ACON Laboratories, Inc. 4108 Sorrento Valley BLvd. San Diego, CA 92121

Re: k012824

> Trade/Device Name: ACON® BAR One Step Barbiturates Test Strip and ACON® BAR One Step Barbiturates Test Strip Device Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS Dated: August 21, 2001 Received: August 23, 2001

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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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# NOV 0 9 2001

#### INDICATIONS FOR USE 10.

# 510(k) Number: K012824

Device Name: ACON® BAR One Step Barbiturates Test Strip

ACON® BAR One Step Barbiturates Test Device

The ACON BAR One Step Barbiturates Test Strip and ACON BAR Indications for Use: One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of barbiturates in human urine at a level relative to the secobarbital cut-off concentration of 300 ng/mL. They are intended for use by healthcare professionals including professionals at point of care sites.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Or

Over-The-Counter Use