INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX

K011057 · OraSure Technologies, Inc. · PJD · Jun 6, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011057
• Device Name: INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
• Applicant: OraSure Technologies, Inc.
• Product Code: PJD · Clinical Chemistry
• Decision Date: Jun 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the collection, preservation, and transport of oral specimens. Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs.

Device Story

Intercept™ Oral Specimen Collection Device collects oral fluid for drug testing. Device consists of treated absorbent cotton fiber pad on nylon stick and preservative solution in plastic vial. Pad is impregnated with salts and gelatin to create hypertonic environment; osmotic gradient enhances flow of mucosal transudate from buccal/gingival mucosa. User places pad between lower cheek and gum; after collection, pad is placed in vial containing preservative to inhibit oral microorganisms. Sealed vial is transported to laboratory for analysis via MICRO-PLATE EIAs. Device facilitates non-invasive specimen collection for detection of drugs of abuse; aids healthcare providers in identifying substance use.

Clinical Evidence

No clinical data provided; device is a specimen collection tool. Substantial equivalence is based on technological characteristics and performance validation of the associated drug assays (referenced in K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010).

Technological Characteristics

Components: absorbent cotton fiber pad, nylon stick, plastic specimen vial. Principle: hypertonic salt/gelatin impregnation creates osmotic gradient to extract mucosal transudate. Preservative solution inhibits oral microbial growth. Standalone collection device; non-electronic.

Indications for Use

Indicated for the collection, preservation, and transport of oral fluid specimens for the detection of cocaine, cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates, and methadone. Intended for use with OraSure Technologies Intercept™ MICRO-PLATE EIAs.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• OraSure® Oral Specimen Collection Device (K970357)

Reference Devices

• K001197
• K000399
• K992918
• K002375
• K993208
• K981341
• K001976
• K002010

Submission Summary (Full Text)

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K011057

## PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.92)

807.92 (8):

| Submitter's Name: | OraSure Technologies, Inc. |
|-------------------|--------------------------------------|
| Address: | 150 Webster St., Bethlehem, PA 18015 |
| Telephone Number: | [phone] |
| Contact Person: | R. Sam Niedbala, Ph.D., BCFE |
| Date Prepared: | March 30, 2001 |

- 2. Device Name: Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device Proprietary Name: Usual Name: Intercept™ Oral Specimen Collection Device Blood Specimen Collection Device Classification Name:
- Device to Which Substantial Equivalence Is Claimed: 3. OraSure® Oral Specimen Collection Device; K970357
- 4. Description of Device:

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosae. The Pad is placed in contact with the gingival mucosa (between the lower cheek and gum) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the Pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

- રું. Intended Use Statement:
The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the collection, preservation, and transport of oral specimens. Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs.

- Comparison of Technological Characteristics: ર્ભ.
The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is substantially equivalent to the OraSure® Oral Specimen Collection Device, K970357. Both devices share major components (collection apparatus and transport containing a preservative solution) and are intended for collecting an oral fluid specimen, and for containing and transporting that specimen. The oral specimens collected with the Intercent™ device, however, can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs as demonstrated in the premarket notifications for the assays (K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010). OraSure Technologies considers this device to be substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

OraSure Technologies, Inc. R. Sam Niedbala, Ph.D., BCFE Chief Science Office 150 WEBSTER ST. BETHELEHEM, PA 18015-1389

FEB 0 6 2015

Re: K011057

Trade/Device Name: Intercept Oral Fluid Drug Test Oral Specimen Collection Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: II Product Code: PJD Dated: March 30, 2001 Received: April 6, 2001

Dear Dr. Niedbala:

This letter corrects our previous Substantially Equivalent (SE) letter of June 6, 2001.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809 ), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for:

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

KOLLOST 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device

Indications For Use:

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the I he miercept ... Olal Fruid Drug Feb Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine intercept -- Oral 'Specifica's 'Sonocacia's 'Sonocamine, methamphetamine, opiates, barbiturates metaoones, cammomores, passere Technologies Intercept™ MICRO-PLATE EIAs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Fred Lacy

(Division Sign-Off) vision of Clinical Laboratory Devices KO11057 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _

c:\fda\indica.doc