(20 days)
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No
The summary describes calibrators and controls for drug testing, which are chemical reagents, not software or devices that would typically incorporate AI/ML. The description focuses on the chemical composition and stability of the product.
No.
This device is a calibrator for laboratory diagnostic assays, not a device used for treating or diagnosing a disease.
No
This device is a calibrator, used for the calibration of diagnostic assays, rather than being a diagnostic device itself. It helps ensure the accuracy of assays that determine amphetamines in human urine.
No
The device description clearly states it is supplied as a liquid in a glass bottle, indicating a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the calibrators are designed for the "determination of amphetamines in human urine on automated clinical chemistry analyzers." This is a classic example of an in vitro diagnostic test, as it involves analyzing a biological sample (urine) outside of the body to provide information about a person's health status (presence of amphetamines).
- Device Description: The description mentions that the calibrators consist of "drug-free human urine" with added analytes. This confirms that the device is used with a human biological sample.
- Anatomical Site: The anatomical site is listed as "human urine," further supporting its use with a biological sample.
- Intended User / Care Setting: The intended user is "automated clinical chemistry analyzers," which are commonly used in clinical laboratories for diagnostic testing.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DKB, DIJ
Device Description
The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine. Drug concentration is determined using GC/MS.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accelerated stability studies (25°C and 37°C) and real time studies were performed to validate the shelf life claim and the opened vial claim of the calibrators/controls. When tested with the Roche immunoassays (currently under development) the calibrators were found to perform well and to be sufficiently stable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 862.3550 Lead test system.
(a)
Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for Quantimetrix Corporation. The logo consists of two overlapping circles with the letters "QC" inside, followed by the words "Quantimetrix Corporation" in a smaller font. Below the logo is the address "2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278-1205".
TEL (800) 624-8380 or (310) 536-0006
FAX (800) 845-1834 or (310) 536-9977
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
K 0308 210 The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
| Proprietary Name: | Preciset® DAT Amphetamine |
|---|---|
| Common Name: | Calibrators/Controls |
| Classification Name: | Calibrators, Drug Mixture |
| Medical specialty: | Clinical Toxicology |
| Product Code: | DKB |
| Device class: | 2 |
| Regulation No: | 862.3200 |
| Manufacturer: | Quantimetrix Corporation |
| 2005 Manhattan Beach Boulevard | |
| Redondo Beach CA 90278 | |
| Phone: 310/536-0006 FAX: 310/536-9977 | |
| Contact Persons: | Gebhard Neyer, Ph.D., Director of R&D, 310-536-0006 |
| Registration No: | 2020715 |
The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine
Drug concentration is determined using GC/MS. The Quantimetrix calibrator is substantially equivalent to the currently marketed Emit®
1
Calibrators/controls manufactured by Syva Company.
Both feature similar matrices, constituents and stability claims.
Intended Use
The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
Performance Characteristics
Accelerated stability studies (25°C and 37°C) and real time studies were performed to validate the shelf life claim and the opened vial claim of the calibrators/controls. When tested with the Roche immunoassays (currently under development) the calibrators were found to perform well and to be sufficiently stable for their intended use.
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 stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 3 2003
Gebhard Neyer, Ph.D. Director, Research & Development Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach, CA 90278
Re: K030826
Trade/Device Name: Preciset® DAT Amphetamine Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DIJ Dated: March 3, 2003 Received: March 14, 2003
Dear Dr. Neyer:
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. Iisting 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page_1_of_____________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): 40308080
Device Name: _____________ Preciset® DAT Amphetamine
Preciset® DAT Amphetamine
Drug of Abuse Calibrators/Controls
Indications For Use:
The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K030826 |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- | -- |
(Per 21 CFR 801.109) (Optional Format 1-2-96)(Optional Format 1-2-96)