VISUALINE BARBITURATES DIPSTRIP TEST

K020136 · Sun Biomedical Laboratories, Inc. · DIS · Mar 20, 2002 · Clinical Toxicology

Device Facts

• Record ID: K020136
• Device Name: VISUALINE BARBITURATES DIPSTRIP TEST
• Applicant: Sun Biomedical Laboratories, Inc.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Mar 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

The Visualine® Barbiturates DipStrip Test is used for qualitative testing for the presence of Secobarbital in urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

Device Story

Visualine® Barbiturates DipStrip Test is an in-vitro diagnostic immunoassay for qualitative detection of barbiturates and metabolites in human urine. Device utilizes competitive immunochromatographic technique on a porous membrane. Input: ~150 uL urine sample. Principle: Drug/metabolite in sample competes with antibody sites on colored microspheres; presence of drug inhibits formation of precipitin at probe site. Output: Visual color comparison; negative sample shows two lines (control + test); positive sample shows one line (control only). Used in clinical settings by medical professionals for preliminary screening. Results require confirmation by more specific alternative methods. Benefits include rapid (5-minute) point-of-care screening for barbiturate presence.

Clinical Evidence

Bench testing only. Correlation study conducted with 201 urine samples comparing Visualine® DipStrip to Hitachi EmitII® assay. Results: 94% sensitivity (95/101), 95% specificity (95/100), 95% efficiency (190/201). Precision/reproducibility studies (within-run, day-to-day, lot-to-lot) reported >99% consistency.

Technological Characteristics

Competitive immunochromatographic assay. Materials: Porous membrane, polyclonal antibodies, colored microspheres. Form factor: DipStrip. Detection: Visual color precipitin formation. Cutoff: 300 ng/ml. Storage: 2-30°C. No ancillary equipment required.

Indications for Use

Indicated for professional use for qualitative screening of Secobarbital in human urine at concentrations ≥ 300 ng/ml.

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).

Reference Devices

• Hitachi EmitII® Barbiturates Assay

Submission Summary (Full Text)

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# SUN BIOMEDICAL LABORATORIES. INC.

604 VPR CENTER, 1001 LOWER LANDING ROAD, BLACKWOOD, NJ 08012 Tel. [phone] Fax. [phone]

MAR 2 0 2002

KD20136

## 510(k) CONTENT SUMMARY

- 1. Name of Manufacturer:
Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, NJ 08012

Visualine® Barbiturates DipStripTest 2. Trade Name:

- 3. Common Name:
An in-vitro immunoassay test by visual color comparison for the detection of Barbiturates and it's metabolites in human urine samples. This test is intended for professional use only.

- 4. Regulation # and Classification:
Reg. #862-3150, Class II Device

#### 5. Test Description:

The Visualine® Barbiturates DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Barbiturates and it's metabolites in urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered in a sample well on the device that holds the porous membrane. When the drug is present in the urine test sample, the drug or drug metabolite competes for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.

A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.

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## 6. Comparison of Two Test Systems for Correlation Studies:

The Visualine® Barbiturates DipStrip Test assay is correlated to the Hitachi Emit The following table illustrates the similarities and differences Barbiturates Assay. between the two assays.

| | Hitachi® Barbiturates Assay | Visualine® Barbiturates<br>DipStrip Test |
|---------------------|--------------------------------------------------------------------|------------------------------------------|
| Test Principle | Homogenous enzyme<br>immunoassay | Competitive binding<br>immunoassay |
| Sample/Sample Size | 200 uL urine | Approx. 150 uL (3 drops) urine |
| Antibody | Polyclonal | Polyclonal |
| Tracer | Drug-Glucose-6-Phosphate<br>Dehydrogenase | Ab Colloidal Complex |
| Detection Method | Change in absorbance (AA) value<br>detected spectrophotometrically | Visual color<br>precipitin formation |
| Test Run Time | 10-20 minutes, dependent on test | 5 minutes |
| Storage Requirement | 2-8°C (36-46°F) | 2-30℃ (36-86°F) |
| Detection Level | 300 ng/ml Barbiturates | 300 ng/ml Barbiturates |
| Ancillary Equipment | Hitachi Emit Calibrators | none |

#### 7. Visualine® Barbiturates DipStrip Test Performance Characteristics

A. Correlation studies between Hitachi Barbiturates Assay and Visualine® Barbiturates DipStrip Test were conducted at Sun Biomedical Laboratories with samples provided by The Lab, Inc. Correlation with Hitachi EmitII® Barbiturates Assay with cutoff at or above 300 ng/ml Barbiturates yielded the following data:

| Sensitivity | 95 / 101 | = 94 % |
|-------------|-----------|--------|
| Specificity | 95 / 100 | = 95 % |
| Efficiency | 190 / 201 | = 95 % |

- B. Specificity and Substances Detected: The test is specific to Barbiturates or structurally related compounds. The test detects Barbiturates at a concentration of 300 ng/ml.
- C. Visualine® Barbiturates DipStrip Test Sensitivity: The sensitivity at 360 ng/ml Barbiturates read at 5 minutes is 94%.
- Precision: Reproducibility studies indicate: D. Within run and run to run > 99 % Within day and day to day > 99 % Within lot and lot to lot > 99 %
- E. Analytical Studies versus precision and accuracy studies: The Visualine® Barbiturates DipStrip Tests detect barbiturates at a cutoff of 300 ng/ml.

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- F. Stability Statement:
Visualine® Barbiturates DipStrip Test stability has been studied. The drug urine tests are tested every three months for up to a period of two years. Visualine® Barbiturates DipStrip Test Kits are stable within their marked expiration date and under the storage conditions as described in the insert.

| 8. Attachments:<br>Correlation Studies | (Accuracy) | Section A |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------|
| Specificity Studies | (Interference substances and cutoff level of<br>Barbiturates detectable by Barbiturates test) | Section B |
| Sensitivity Studies | (Analytical studies) | Section C |
| Reproducibility Studies | (Precision) | Section D |
| Visualine® Barbiturates<br>DipStripTest Package Insert | | Section E |
| Label Copies | | Section F |
| Hitachi Emit Barbiturates<br>Assay Insert | | Section G |
| Stability Study | | Section H |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

# MAR 2 0 2002

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ming Sun, Ph.D. President Sun Biomedical Laboratories Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, NJ 08012

Re: k020136

Trade/Device Name: Visualine® Barbiturates DipStrip Test Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS Dated: January 11, 2002 Received: January 15, 2002

Dear Dr. Sun:

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 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 I his ication. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. THE I Dr 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 II you desire specific a in vitro diagnostic devices), please contact the Office of Compliance at additionally 8011 o ditionally, for questions on the promotion and advertising of your device, [phone]. I radiations 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 mioritation on 5 var reserver Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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SUN BIOMEDICAL LABORATORIES, INC.

604 VPR CENTER, 1001 LOWER LANDING ROAD, BLACKWOOD, NJ 08012 Fax. [phone] Tel. [phone]

Page 1 of 1

K020136 510 (k) Number:

DEVICE NAME: Visualine®Barbiturates DipStrip Test

INDICATIONS FOR USE: The Visualine® Barbiturates DipStrip Test is used for qualitative testing for the presence of Secobarbital in urine samples at or above300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result.| This test is intended for use by medical professionals.

Kull

(Division Sign-Off) Division of Clinical Laboratory 510(k) Number K 11/2/12/12/12/2017

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The Counter-Use (Optional Format 1-2-96)

page 3 revised 3/15/2