(27 days)
Not Found
No
The device description and intended use clearly define the product as calibrators and controls for enzyme immunoassays, which are chemical reagents used for calibration and validation, not software or systems that would typically incorporate AI/ML. The document explicitly states "These Calibrators and Controls do not have any especially unique technical characteristics" and mentions confirmation by GC/MS, a standard analytical technique. There is no mention of AI, ML, or related concepts in the provided text.
No.
The device is described as "in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays" and "validation of their respective DAU enzyme immunoassays," indicating that it is used for diagnostic purposes rather than for treating a condition.
No
These devices (calibrators and controls) are used to calibrate and validate diagnostic assays, but they are not diagnostic devices themselves. They do not directly detect, diagnose, or treat any condition. The "Intended Use / Indications for Use" explicitly states they are "intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays" and "for the validation of their respective DAU enzyme immunoassays."
No
The device is described as liquid, human urine-based calibrators and controls, which are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states that the devices are "intended for in vitro diagnostic use".
- Function: The devices are used to calibrate and validate enzyme immunoassays for detecting drugs of abuse in human urine. This is a diagnostic process performed in vitro (outside the body) on a biological sample (urine) to provide information about a person's health status (presence of drugs).
- Device Description: The description details the composition of the calibrators and controls, which are prepared with known concentrations of drug analytes in a human urine matrix. This further supports their use in a laboratory setting for diagnostic testing.
The information provided aligns perfectly with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.
The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.
Product codes (comma separated list FDA assigned to the subject device)
DLJ, LAS
Device Description
All of the Single Analyte Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. When applicable, they contain known concentration of a specific drug analyte.
The Negative DAU Calibrator is a processed, drug-free human urine matrix. The Low, Cutoff, Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:
| Phencyclidine EIA | Opiate EIA | Cocaine Metabolite EIA | Amphetamines EIA | |
|---|---|---|---|---|
| Reference Material | Phencyclidine | Morphine | Benzoylecgonine | d-Methamphetamine |
| Low Calibrator | 12.5 ng/mL | 150 ng/mL | 150 ng/mL | 500 ng/mL |
| Cutoff Calibrator | 25 ng/mL | 300 ng/mL | 300 ng/mL | 1000 ng/mL |
| Intermediate Calibrator | 50 ng/mL | 600 ng/mL | 1000 ng/mL | 1500 ng/mL |
| High Calibrator | 100 ng/mL | 1000 ng/mL | 3000 ng/mL | 2000 ng/mL |
| Control Level 1 | 18 ng/mL | 225 ng/mL | 225 ng/mL | 750 ng/mL |
| Control Level 2 | 32 ng/mL | 375 ng/mL | 375 ng/mL | 1250 ng/mL |
The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed by GC/MS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
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)
Performance characteristics on precision, accuracy and stability are similar to the predicate device.
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
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary of Safety and Effectiveness
APR 0 3 2002
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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, and Contact
Lin-Zhi International, Inc. 2391 Zanker Road. Suite 340 San Jose, CA 95131 Phone: (408) 944-0360 (408) 944-0359 Fax:
Contact: Chiu Chin Chang, Ph.D. VP, R&D
Device Name and Classification
| (a) Classification Name: | Calibrators, Drug Specific;
Class II, DLJ (91 Toxicology), 21 CFR 862.3200 |
|--------------------------|---------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Phencyclidine Calibrators,
Opiate Calibrators,
Cocaine Calibrators, and
Amphetamine Calibrators |
| Proprietary Name: | None |
| (b) Classification Name: | Single (Specified) Analyte Controls (Assayed and Unassayed);
Class I, LAS (91 Toxicology), 21 CFR 862.3280 |
| Common/Usual Name: | Phencyclidine Controls,
Opiate Controls,
Cocaine Controls, and
Amphetamines Controls |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.' Single Analyte Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to the Drugs of Abuse Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notification K983159.
1
Device Description
All of the Single Analyte Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. When applicable, they contain known concentration of a specific drug analyte.
The Negative DAU Calibrator is a processed, drug-free human urine matrix. The Low, Cutoff, Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:
| Phencyclidine EIA | Opiate EIA | Cocaine Metabolite EIA | Amphetamines EIA | |
|---|---|---|---|---|
| Reference Material | Phencyclidine | Morphine | Benzoylecgonine | d-Methamphetamine |
| Low Calibrator | 12.5 ng/mL | 150 ng/mL | 150 ng/mL | 500 ng/mL |
| Cutoff Calibrator | 25 ng/mL | 300 ng/mL | 300 ng/mL | 1000 ng/mL |
| Intermediate Calibrator | 50 ng/mL | 600 ng/mL | 1000 ng/mL | 1500 ng/mL |
| High Calibrator | 100 ng/mL | 1000 ng/mL | 3000 ng/mL | 2000 ng/mL |
| Control Level 1 | 18 ng/mL | 225 ng/mL | 225 ng/mL | 750 ng/mL |
| Control Level 2 | 32 ng/mL | 375 ng/mL | 375 ng/mL | 1250 ng/mL |
The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed by GC/MS.
Intended Use
The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.
The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.
Comparison to Predicate Device
LZI's Single Analyte Urine DAU Calibrators and Controls are similar in intended use, matrix, and performance to the DRI's Drugs of Abuse Urine Calibrators and Controls.
Similarities:
- Both are for the calibration and validation of DAU enzyme immunoassays to detect the . same commonly abused drug analytes (phencyclidine, opiates, cocaine metabolite, or amphetamines) in human urine.
2
- The cutoff concentration for each analyte is the same per recommendations of The . Substance Abuse and Mental Health Services Administration (SAMHSA).
- Both use 2 levels of Controls, and the concentrations are set at equal to or approximately . ± 25% of the cutoff concentration for each analyte according to the SAMHSA guideline.
- The nominal concentrations of the analyte in the calibrators and controls are determined . and confirmed by GC/MS.
- . Both are urine-based liquids.
- . Storage condition is the same, at 2℃ to 8℃.
- Performance characteristics on precision, accuracy and stability are similar. �
| Characteristics | DRI's DAU Urine
Calibrators and Controls | LZI's Single Analyte Urine
DAU Calibrators and Controls |
|--------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| No. of Analytes in each
Calibrator or Control | All 4 drugs in each Calibrator or Control | Single drug only in each
Calibrator or Control. |
| No. of Calibrators | 3 levels* including the
Negative Calibrator. | 5 levels including the Negative
Calibrator |
| Nomenclature/Labeling
of Calibrators | Negative, Low (= Cutoff),
and High | Negative, Low, Cutoff,
Intermediate, and High |
| Concentration of
Analyte(s) | Phencyclidine Controls: 20
and 35 ng/mL
Cocaine High Calibrator:
1000 ng/mL | Phencyclidine Controls: 18 and
32 ng/mL,
Cocaine High Calibrator: 3000
ng/mL |
Differences:
- Additional calibrators are now available. Currently 5 levels of calibrators (Cal 0, 1, 2, 3, and 4) are available from DRI/Microgenics Corp. (under "Multi-drug Urine Calibrators and Controls" product name).
Conclusion
The information provided in the premarket notification demonstrates that the LZI's Single Analyte Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to previously approved predicate devices, notably the DRI's DAU Urine Calibrators and Controls, and safe and effective for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services U.S.A. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract shapes resembling human profiles or figures, stacked on top of each other.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Chiu Chin Chang, Ph.D. VP, R&D Lin-Zhi International, Inc. 2391 Zanker Road - Suite 340 San Jose, CA 95131
APR 0 3 2002
K020769 Re:
Trade/Device Name: Single Analyte Urine Drugs of Abuse Calibrators and Controls Regulation Number: 21 CFR 862.3280; 21 CFR 862.3200 Regulation Name: Clinical toxicology control material; Clinical toxicology calibrator Regulatory Class: Class I; Class II Product Code: LAS; DLJ Dated: February 28, 2002 Received: March 7, 2002
Dear Dr. Chang:
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 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification
Indications for Use Statement
510(k) Number (if known): K020769
Device Name: Single Analyte Urine Drugs of Abuse Calibrators and Controls
Indications for Use:
The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.
The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.
P. Bernhardt for J. Cooper
ision of Clinical Laboratory Devices 510(k) Number LO2 O
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)