(61 days)
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.
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.
This document pertains to the Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device. It is a collection device, so the performance criteria focuses on the ability to collect and preserve samples for subsequent drug testing, rather than direct diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list quantitative acceptance criteria for the device's performance in a table format, nor does it present specific performance data from a study.
However, the core of the submission (K011057) is a claim of substantial equivalence to a predicate device (OraSure® Oral Specimen Collection Device; K970357). The "performance" in this context is implicitly tied to demonstrating that the new device can effectively collect and preserve samples for the same range of drug detection as the predicate and extend this capability to additional drugs when paired with specific assays.
Implicit Acceptance Criteria (derived from the text):
| Acceptance Criteria Category | Specifics | Reported Device Performance |
|---|---|---|
| I. Core Functionality (Substantial Equivalence) | - Collection Capability: Ability to effectively collect an oral fluid specimen. - Preservation Capability: Ability to preserve the collected specimen. - Transport Capability: Ability to transport the specimen securely to a laboratory. | "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." This implies the new device performs these core functions comparably to the predicate. |
| II. Compatibility with Downstream Assays (Extended Use) | - Detection of Cocaine & Metabolites: Compatibility with assays for these substances. - Detection of Cannabinoids: Compatibility with assays for these substances. - Detection of Phencyclidine: Compatibility with assays for this substance. - Detection of Amphetamine: Compatibility with assays for this substance. - Detection of Methamphetamine: Compatibility with assays for this substance. - Detection of Opiates: Compatibility with assays for these substances. - Detection of Barbiturates: Compatibility with assays for these substances. - Detection of Methadone: Compatibility with assays for these substances. | "The oral specimens collected with the Intercept™ device, however, 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 as demonstrated in the premarket notifications for the assays (K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010)." This indicates successful validation of compatibility with specific assays. |
2. Sample Size and Data Provenance for Test Set:
The provided 510(k) summary does not detail a specific "test set" sample size or data provenance for a direct clinical performance study of the collection device itself.
Instead, the submission relies on:
- Substantial Equivalence: By claiming substantial equivalence to the OraSure® Oral Specimen Collection Device (K970357), it implicitly asserts that the new device performs similarly for its core functions.
- Referenced PMA/510(k)s for Assays: For the extended detection capabilities, the document refers to multiple separate premarket notifications (K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010) for the OraSure Technologies Intercept™ MICRO-PLATE EIAs. The performance data for detecting the specific drugs with oral specimens collected by this device would be detailed within those referenced assay submissions.
Therefore, without access to those referenced documents, we cannot provide details on the test set sample size or data provenance for the drug detection capabilities.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
The document does not mention the use of experts to establish ground truth specifically for the collection device's performance in this 510(k) summary. This is consistent with a substantial equivalence claim for a collection device, where the focus is on physical and functional similarity to an already cleared device, and the analytical performance (e.g., drug detection accuracy) is tied to the separate assays.
4. Adjudication Method for Test Set:
Not applicable, as no direct "test set" and ground truth establishment by experts for the collection device itself is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is a collection device, not an AI-assisted diagnostic tool or a device that requires human interpretation in the way an imaging AI might. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This device is a manual specimen collection device and does not involve an algorithm for standalone performance. Its "performance" is its ability to successfully collect and preserve an oral fluid specimen for laboratory analysis.
7. Type of Ground Truth Used:
For the collection device's core functionality, the "ground truth" is implied by its functional equivalence to the predicate device and its ability to deliver a specimen suitable for subsequent laboratory analysis.
For the drug detection claims, the ground truth would be established during the development and validation of the specific EIAs (Enzyme Immunoassays) as detailed in the referenced K numbers. This type of ground truth typically involves:
- Analytical Standards: Known concentrations of drugs and their metabolites.
- Spiked Samples: Oral fluid samples to which known amounts of drugs have been added.
- Clinical Samples with Confirmed Results: Oral fluid samples from actual subjects, where drug presence/absence and concentration have been independently confirmed by more definitive methods (e.g., GC/MS or LC/MS-MS, considered the gold standard for drug testing).
8. Sample Size for the Training Set:
The document does not specify a training set sample size. As a collection device, it does not typically involve traditional machine learning "training sets" in the same way an AI diagnostic algorithm would. Its design and functional validation would be based on engineering principles, materials science, and compatibility testing with chemical assays.
9. How Ground Truth for Training Set Was Established:
Not applicable, as a traditional "training set" with ground truth in the context of an algorithm or machine learning is not described or relevant for this type of device. The "ground truth" for the device's design and functionality would be based on:
- Established methods for oral fluid collection.
- Chemical stability validation for the preservative solution ensuring drug integrity.
- Compatibility testing with the OraSure Technologies Intercept™ MICRO-PLATE EIAs (which themselves would have their own established ground truth).
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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.
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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 (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
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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.
(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
§ 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.