(61 days)
No
The device description focuses on a physical collection device and preservative solution, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".
No.
This device is designed for the collection, preservation, and transport of oral specimens for drug detection, not for treating any medical condition or disease.
No
The device is for collection, preservation, and transport of oral specimens, not for direct diagnosis of diseases or conditions. The collected specimens can then be used in laboratory tests to detect substances, but the collection device itself is not a diagnostic tool.
No
The device description clearly outlines physical components (cotton fiber pad, nylon stick, plastic container, preservative solution) and a physical collection process, indicating it is a hardware device, not software-only.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the collected oral specimens "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." This describes a test performed in vitro (outside the body) on a biological specimen to provide information about a person's health or condition (in this case, the presence of drugs).
- Device Description: The device is designed for the "collection, preservation, and transport of oral specimens" specifically for laboratory testing. This aligns with the function of a device used in an IVD process.
- Predicate Device: The predicate device listed (K970357; OraSure® Oral Specimen Collection Device) is also an oral fluid collection device used for drug testing, which is a common type of IVD.
The device itself is a collection and preservation tool, but its intended use is directly linked to an in vitro diagnostic test (the OraSure Technologies Intercept™ MICRO-PLATE EIAs). Therefore, it is considered an IVD device because it is an accessory to and intended for use with an IVD test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PJD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mucosal transudate onto the absorptive cotton fibers of the Pad. The Pad is placed in contact with the gingival mucosa (between the lower cheek and gum)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1675 Blood specimen collection device.
(a)
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.(b)
Classification. Class II.
0
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: | (610) 882-1820 |
| Contact Person: | R. Sam Niedbala, Ph.D., BCFE |
| Date Prepared: | March 30, 2001 |
-
- 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
-
- 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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem. The logo is presented in black and white.
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
2
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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