(397 days)
Not Found
No
The device description details a chemical assay based on kinetic interaction of microparticles, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic test used for detecting Phencyclidine in human oral fluid, not for treating or preventing a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test..."
No
The device description clearly outlines a chemical assay based on kinetic interaction of microparticles in a solution (KIMS) technology, involving reagents, calibrators, and controls. This is a hardware-based in vitro diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid".
- In Vitro: The test is performed on a biological specimen (oral fluid) outside of the living body.
- Diagnostic: While it provides a preliminary result and requires confirmation, its purpose is to detect the presence of a substance (Phencyclidine) in a sample to aid in a diagnostic process (drug testing).
- Device Description: The description details the technology used to analyze the oral fluid sample, which is characteristic of an in vitro diagnostic device.
The document clearly identifies the device as an IVD through its intended use and the nature of the testing it performs.
N/A
Intended Use / Indications for Use
DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.
DAT Oral Fluid Phencyclidine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Oral Fluid DAT Control Set A is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
The Oral Fluid DAT Qual Cal calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
The Oral Fluid DAT SQ Cal A calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
Product codes (comma separated list FDA assigned to the subject device)
LCM, DKB, DIF
Device Description
The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
Multi-analyte calibrator and control solutions are prepared from NIST traceable, commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically by spiking phencyclidine into a synthetic oral fluid matrix at the following concentrations: 0, 1, 2, 4, 8, and 16 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral fluid
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.
Not Found
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
N/A
0
K093989
510(k) Summary: Oral Fluid Phencyclidine Assay
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |
|---|---|---|
| Submitter | ||
| Name, Address, | ||
| Contact | Roche Diagnostics | |
| 9115 Hague Rd. | ||
| Indianapolis, IN 46250 | ||
| 317-521-3742 | JAN 25 2011 | |
| Contact Person: Michelle Neff | ||
| Date Prepared: January 27, 2011 | ||
| Device Name | Proprietary name: Oral Fluid Phencyclidine Assay | |
| Common name: Phencyclidine test system | ||
| Classification name: Enzyme Immunoassay, Phencyclidine | ||
| Product Code: LCM | ||
| Device | ||
| Description | The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug. | |
| Multi-analyte calibrator and control solutions are prepared from NIST traceable. commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically by spiking phencyclidine into a synthetic oral fluid matrix at the following concentrations: 0, 1, 2, 4, 8, and 16 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS. |
1
| Intended Use | DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS. |
|---|---|
| DAT Oral Fluid Phencyclidine provides only a preliminary |
analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
| Comparison to |
|---|
| Predicate Device |
The Oral Fluid Phencyclidine assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, we claim substantial equivalence to the currently marketed PCP Intercept® Micro-Plate EIA assay (K000399).
| Feature | Roche Oral Fluid Phencyclidines Assay | Predicate Device: PCP Intercept®
MICRO-PLATE EIA (K000399) |
|--------------|---------------------------------------------------------------------------|--------------------------------------------------------------------|
| Methodology | KIMS, Kinetic interaction of microparticles in
solution | Competitive micro-plate immunoassay |
| Sample Type | Oral Fluid | Oral Fluid |
| Intended Use | Qualitative and semi-quantitative detection of
Phencyclidine | Qualitative detection of Phencyclidine |
| Neat Cutoff | 6 ng/mL | 3 ng/mL |
| Controls | Synthetic oral fluid matrix:
Zero, Negative (.5X), and Positive (1.5X) | Synthetic oral fluid matrix:
Negative (.5X) and Positive (1.5X) |
| Calibrator | Synthetic oral fluid matrix:
Zero, .5X, Cutoff, 2X, 4X, and 8X | Synthetic oral fluid matrix:
Zero, Cutoff |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings. The emblem is black, while the text and the circle are a lighter color, possibly white or light gray.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Ms. Michelle Lee Neff 9115 Hague Road Indianapolis, IN, 46250
Re: K093989
Trade Name: DAT Oral Fluid Phencyclidine Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: LCM, DKB. DIF Dated: January 7, 2011 Received: January 24, 2011
JAN 2 5 2011
Dear Ms. Neff:
100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): K093989
Device Name: DAT Oral Fluid Phencyclidine
Indications for Use:
DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.
DAT Oral Fluid Phencyclidine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093989
Page 1 of 2
5
Indications for Use Form
510(k) Number (if known): K093989
Device Name: DAT Oral Fluid Phencyclidine
Indications for Use:
The Oral Fluid DAT Control Set A is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
The Oral Fluid DAT Qual Cal calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
The Oral Fluid DAT SQ Cal A calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carl
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093989
Page 2 of 2