(59 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement. There is no mention of AI, ML, or any computational learning processes.
No
Explanation: This device is an in vitro diagnostic (IVD) immunoassay designed for detecting barbiturates in human urine, used for diagnostic purposes and monitoring, not for direct therapeutic treatment.
Yes
The intended use explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose." This clearly indicates its role as a diagnostic device.
No
The device is a homogeneous enzyme immunoassay, which is a chemical reagent-based test, not a software-only device. It is intended for use with automated clinical chemistry analyzers, which are hardware devices.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the assay is intended for "qualitative and semiquantitative analyses of barbiturates in human urine." It also mentions the use of the results in the "diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy." These are all activities performed in vitro (outside the body) on a biological specimen (urine) for diagnostic and treatment purposes.
- Device Description: The description details a laboratory assay that uses reagents and measures enzyme activity spectrophotometrically. This is characteristic of an in vitro test.
- Calibrators and Controls: The description of the calibrators and controls explicitly states they are "intended for in vitro diagnostic use."
- Professional Use: The assay is designed for "professional use with a number of automated clinical chemistry analyzers," indicating it is used in a clinical laboratory setting for diagnostic testing.
- Predicate Devices: The listed predicate devices (Emit® II Plus Barbiturate Assay and Multi-Drugs Urine Calibrators and Controls) are also IVD devices, further supporting the classification of this device as an IVD.
Therefore, based on the provided information, the Barbiturate Enzyme Immunoassay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.
The Barbiturate Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.
The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.
Product codes
DIS, DLJ, LAS
Device Description
LZI's Barbiturate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect barbiturates in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between barbiturate labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
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. Each contains a known concentration of a specific drug analyte.
The Negative DAU calibrator is a processed, drug-free human urine matrix, which has also been used with all assays. The calibrators and controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix.
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
Professional use with a number of automated clinical chemistry analyzers.
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 including precision, sensitivity, accuracy, analytical recovery, and specificity were evaluated.
Precision:
Within Run Precision (Qualitative - mA/min.):
Negative: Mean 269.1, SD 2.2, %CV 0.8
100 ng/mL: Mean 311.1, SD 1.9, %CV 0.6
200 ng/mL: Mean 354.2, SD 3.7, %CV 1.1
300 ng/mL: Mean 385.1, SD 3.1, %CV 0.1
400 ng/mL: Mean 404.7, SD 2.9, %CV 0.7
1000 ng/mL: Mean 445.3, SD 2.7, %CV 0.6
Within Run Precision (Semi-quantitative - ng/mL):
100 ng/mL: Mean 99.0, SD 4.7, %CV 4.8
200 ng/mL: Mean 194.7, SD 7.4, %CV 3.8
300 ng/mL: Mean 294.3, SD 8.3, %CV 2.8
400 ng/mL: Mean 386.5, SD 13.7, %CV 3.6
Secobarb only
Run-To-Run Precision (Qualitative - mA/min.):
Negative: Mean 271.1, SD 2.3, %CV 0.8
100 ng/mL: Mean 314.8, SD 2.2, %CV 0.7
200 ng/mL: Mean 359.0, SD 1.9, %CV 0.5
300 ng/mL: Mean 389.5, SD 1.7, %CV 0.4
400 ng/mL: Mean 405.6, SD 1.8, %CV 0.4
1000 ng/mL: Mean 447.4, SD 1.6, %CV 0.4
Run-To-Run Precision (Semi-quantitative - ng/mL):
100 ng/mL: Mean 102.7, SD 3.2, %CV 3.1
200 ng/mL: Mean 191.6, SD 9.3, %CV 4.9
300 ng/mL: Mean 290.3, SD 14.0, %CV 4.8
400 ng/mL: Mean 385.3, SD 12.7, %CV 3.3
Sensitivity: 25 ng/mL
Accuracy:
Vs. Syva (n=105):
Positive Samples: 91.1 % agreement (100% vs. GC/MS /HPLC)
Negative Samples: 100 % agreement
Analytical Recovery:
Qualitative: 100 % accuracy on positive vs. negative tests
Semi-quantitative: Quantitates within +/-15% of the nominal concentration between 40 ng/mL and 800 ng/mL.
Specificity: Comparable to the predicate device.
All studies showed acceptable results when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25 ng/mL.
Accuracy (Positive Samples): 91.1 % agreement (100% vs. GC/MS /HPLC).
Accuracy (Negative Samples): 100 % agreement.
Analytical Recovery (Qualitative): 100 % accuracy on positive vs. negative tests.
Analytical Recovery (Semi-quantitative): Quantitates within +/-15% of the nominal concentration between 40 ng/mL and 800 ng/mL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
NOV - 3 2003
September 1, 2003
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850
RE: Premarket Notification [510(k)] for Barbiturate Enzyme Immunoassa
Attention: Document Control Clerk
In accordance with the requirements of the Section 510(k) of the Federal Fod Cosmetic Act, Lin-Zhi International, Inc. hereby notifies you of its intention to introdu into interstate commerce for commercial distribution of the Barbiturate Enzyme Immunoassay for qualitative and semi-quantitative determination of barbiturates in human urine.
This test kit is based on the principle of specific inhibition of enzyme activity of an enzyme-drug conjugate by the specific antibody to the drug, which is identical to the homogeneous enzyme immunoassay currently available Emit® II Plus Barbiturate Assay by Syva Company (Dade Behring Inc.) in the commercial distribution.
The following information is being submitted in conformance to the requirements of 21 CFR 807.87:
| 1. | Classification Name:
Common/Usual Name: | Barbiturate Test System
Homogeneous enzyme immunoassay for the determination
of Barbiturates levels in urine. |
|----|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proprietary Name: | None |
| | 2. Establishment
Registration Number: | 3003610499 |
| | 3. Classification: | The Barbiturate test system has been placed in Class II
by the Bureau of Medical Devices.
Classification Number: DIS (21 CFR 862.3150)
Panel: 91 Toxicology |
| | 4. Performance Standards: | No applicable standards have been established under Section 51- of the Act. |
1
510(k) Summary of Safety and Effectiveness
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. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849
| Contact: | Cheng-I Lin, Ph.D.
President, R&D Director |
| ---------- | ----------------------------------------------- |
|---|
Device Name and Classification
| Classification Name: | Barbiturate test system, Class II,
DIS (91 Toxicology),
21CFR 862.3150 |
|----------------------|------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous enzyme immunoassay for the determination of
Barbiturates levels in urine. |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.' Barbiturate Enzyme Immunoassay is substantially equivalent to Syva EMIT® II Plus Barbiturate Assay (By Syva Company-Dade Behring Inc.), cleared under premarket notification K010934.
LZI's Barbiturate Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
LZI's Barbiturate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect barbiturates in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
2
The assay is based on competition between barbiturate labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine.
Comparison to Predicate Device
LZI's Barbiturate Enzyme Immunoassay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed Emit® II Plus Barbiturate Assay (K010934) by Syva Company-Dade Behring Inc.
The following table compares LZI's Barbiturate Enzyme Immunoassay with the predicate device, Emit® II Plus Barbiturate Assay by Syva Company-Dade Behring Inc.
Similarities:
- . Both assays are for qualitative and semi-quantitative determination of barbiturates in human urine.
- Both have dual cutoff design (200 ng/mL or 300 ng/mL). .
- Both assays use 5 points calibration for semi-quantitative determination. .
- Both assays use secobarbital as calibrators and controls. ●
- Both assays use the same method principle, and device components. .
Difference:
- . Syva's assay uses 150, 225, 250, 375 ng/mL for various control levels. LZI's assay uses 100, 200, 300, 400 ng/mL for various control levels.
- Syva's assay uses 0, 100, 200, 300 and 800 ng/mL, LZI's assay uses 0, 100, . 200, 300 and 1000 ng/mL 5 points calibration for semi-quantitative assay.
3
Performance Characteristics
| Feature | SYVA's Barbiturate EIA | LZI's Barbiturate EIA | ||||||
|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | ||||||||
| Qualitative: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 205.8 | 0.9 | 0.4 | Negative | 269.1 | 2.2 | 0.8 | |
| 150 ng/mL | 242.1 | 1.0 | 0.4 | 100 ng/mL | 311.1 | 1.9 | 0.6 | |
| 200 ng/mL | 258.4 | 1.2 | 0.5 | 200 ng/mL | 354.2 | 3.7 | 1.1 | |
| 225 ng/mL | 266.9 | 1.1 | 0.4 | 300 ng/mL | 385.1 | 3.1 | 0.1 | |
| 250 ng/mL | 276.4 | 1.2 | 0.4 | 400 ng/mL | 404.7 | 2.9 | 0.7 | |
| 300 ng/mL | 295.8 | 1.4 | 0.5 | 1000 ng/mL | 445.3 | 2.7 | 0.6 | |
| 375 ng/mL | 326.4 | 1.2 | 0.4 | |||||
| Semi-quantitative: | (ng/mL) | Mean | SD | %CV | (ng/mL) | Mean | SD | %CV |
| 150 ng/mL | 144.0 | 5.5 | 3.8 | 100 ng/mL | 99.0 | 4.7 | 4.8 | |
| 200 ng/mL | 191.4 | 3.5 | 1.8 | 200 ng/mL | 194.7 | 7.4 | 3.8 | |
| 225 ng/mL | 215.7 | 3.2 | 1.5 | 300 ng/mL | 294.3 | 8.3 | 2.8 | |
| 250 ng/mL | 242.6 | 3.4 | 1.4 | 400 ng/ml | 386.5 | 13.7 | 3.6 | |
| 300 ng/mL | 297.9 | 4.0 | 1.3 | Secobarb only | ||||
| 375 ng/mL | 390.1 | 3.8 | 1.0 | |||||
| Run-To-Run Precision: | ||||||||
| Qualitative: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 205.8 | 1.2 | 0.6 | Negative | 271.1 | 2.3 | 0.8 | |
| 150 ng/mL | 242.1 | 1.4 | 0.6 | 100 ng/mL | 314.8 | 2.2 | 0.7 | |
| 200 ng/mL | 258.4 | 1.5 | 0.6 | 200 ng/mL | 359.0 | 1.9 | 0.5 | |
| 225 ng/mL | 266.9 | 1.7 | 0.6 | 300 ng/mL | 389.5 | 1.7 | 0.4 | |
| 250 ng/mL | 276.4 | 1.7 | 0.6 | 400 ng/mL | 405.6 | 1.8 | 0.4 | |
| 300 ng/mL | 295.8 | 1.9 | 0.6 | 1000 ng/mL | 447.4 | 1.6 | 0.4 | |
| 375 ng/mL | 326.4 | 2.3 | 0.7 | P 13 | ||||
| Semi-quantitative: | (ng/mL) | Mean | SD | %CV | (ng/mL) | Mean | SD | %CV |
| 150 ng/mL | 144.0 | 6.0 | 4.2 | 100 ng/mL | 102.7 | 3.2 | 3.1 | |
| 200 ng/mL | 191.4 | 4.5 | 2.4 | 200 ng/mL | 191.6 | 9.3 | 4.9 | |
| 225 ng/mL | 215.7 | 4.1 | 1.9 | 300 ng/mL | 290.3 | 14.0 | 4.8 | |
| 250 ng/mL | 242.6 | 5.8 | 2.4 | 400 ng/ml | 385.3 | 12.7 | 3.3 | |
| 300 ng/mL | 297.9 | 6.2 | 2.1 | P. 19 | ||||
| 375 ng/mL | 390.1 | 7.3 | 1.9 | |||||
| Sensitivity: | 20 ng/mL | 25 ng/mL | ||||||
| Accuracy: | Vs. a commercial EIA | Vs. Syva (n=105) | ||||||
| Positive Samples: | 95.6 % agreement | 91.1 % agreement(100% vs. GC/MS /HPLC) | ||||||
| Negative Samples: | 99% agreement | 100 % agreement | ||||||
| Analytical Recovery: | ||||||||
| Qualitative: 100 % accuracy on positive vs. negative tests | 100 % accuracy on positive vs. negative tests | |||||||
| Semi-quantitative | Quantitates within ±15% of the nominal | Quantitates within ±15% of the nominal | ||||||
| concentration between 40 ng/mL and 900 | concentration between 40 ng/mL and 800 | |||||||
| ng/mL. | ng/mL. | |||||||
| Specificity: | See attached Syva's Barbiturate Assay | Comparable to the predicate device. | ||||||
| package insert |
the life
រូប
4
Conclusion
LZI's Barbiturate Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.
We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Barbiturate Enzyme Immunoassay to other Barbiturate test systems currently marketed in the United States.
5
510(k) Summary of Safety and Effectiveness
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. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849
| Contact: | Cheng-I Lin, Ph.D |
|---|---|
| President |
Device Name and Classification
| (a) Classification Name: | Calibrators, Drug Specific;
Class II, DLJ (91 Toxicology), 21 CFR 862.3200 |
|--------------------------|---------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Secobarbital 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: | Secobarbital Controls |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.'s Barbiturate Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to the DRI's secobarbital calibrators and controls included in the Multi-Drugs Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notifications (K935101) for Drugs of Abuse Urine Calibrators and Controls.
6
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. Each contains a known concentration of a specific drug analyte.
The Negative DAU calibrator is a processed, drug-free human urine matrix, which has also been used with all assays. The calibrators and controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The concentrations of drug analyte in the barbiturate calibrators and controls are summarized as follows:
| Barbiturate EIA | |
|---|---|
| Reference Material | Secobarbital |
| Calibrator #2/Control I | 100 ng/mL |
| Calibrator #3/Cutoff A/Control II | 200 ng/mL |
| Calibrator #4/Cutoff B/Control III | 300 ng/mL |
| Calibrator #5 | 1000 ng/mL |
| Control IV | 400 ng/mL |
Intended Use
The Barbiturate DAU Calibrators are intended for in vitro diagnostic use for the calibration of the barbiturate enzyme immunoassay to detect barbiturates in human urine. The Barbiturate DAU Controls are intended for in vitro diagnostic use for the validation of the barbiturate enzyme immunoassay to detect barbiturates in human urine.
Comparison to Predicate Device
LZI's Barbiturate DAU Calibrators and Controls are similar in intended use, matrix, and performance to the DRI's secobarbital calibrators and controls included in the Multi-Drug Urine Calibrators and Controls.
Similarities:
- Both are for the calibration of Barbiturate Enzyme Immunoassay to detect ● drug of abuse in human urine.
- A total of 5 levels of calibrators including the negative calibrator for each analyte. ●
- 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. ●
7
Differences:
- The DRI's cutoff concentration is 200 ng/mL; LZI has 200 and 300 ng/mL cutoffs. .
- For semi-quantitative assay, DRI uses 0, 100, 200, 500, and 1000 ng/mL as calibrators. . LZI uses 0, 100, 200, 300, and 1000 ng/mL as calibrators.
- LZI uses 100 and 300 ng/mL as controls for 200 ng/mL cutoff, and uses 200 and 400 . ng/mL as controls for 300 ng/mL cutoff. DRI uses 150 and 300 ng/mL as controls for 200 ng/mL cutoff calibrator.
Conclusion
The information provided in the premarket notification demonstrates that the LZI's Barbiturate Drug of Abuse Calibrators and Controls are substantially equivalent to previously approved predicate devices, notably the DRI's Multi-Drug Urine Calibrators and Controls, and safe and effective for its intended use.
8
| 5. Product Description: | Draft copies of
(Attachment A) Product Insert, and
(Attachment B) Product Labels, are submitted along with
(Attachment C) Product Inserts from
(i) Emit® II Plus Barbiturate Assay (by Dade
Behring Inc.),
(ii) Barbiturate Enzyme Immunoassay (DRI) |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. Substantial Equivalence: | The test kit utilizes specific antibody and antigen-enzyme
conjugate binding principle identical to those used in the
Enzyme Multiplied Immunoassay Technology (EMIT®).
The reagent formulation is similar to those described in
the Emit® II Plus Barbiturate Assay (by Dade Behring
Inc.). Examination of the enclosed data will indicate that
the current Barbiturate Enzyme Immunoassay is
substantially equivalent to other commercially available
test kits for determination of barbiturates in human urine. |
We trust the information that we have provided is satisfactory and look forward to your review of this submission.
Furthermore, a truthful and accurate statement, a 510 (k) summary, and an indications for use statement regarding to the current Barbiturate Enzyme Immunoassay are also submitted in accordance to the requirements of the 21 CFR 807.87(J), SMDA 1990, and 21 CFR807.92.
Sincerely,
Chang-Li Lin, Ph.D.
Cheng-I Lin, Ph.D. President, R&D Director Lin-Zhi International, Inc.
Confidentiality
Lin-Zhi International requests the FDA not to disclose the nature or existence of the Premarket Notification until the substantial equivalence decision has been reached.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
NOV - 3 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cheng-I Lin, Ph.D. President, R & D Director Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085
Re: K032764
Trade/Device Name: Barbiturate Enzyme Immunoassay Barbiturate Drug of Abuse Calibrators and Controls Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS; DLJ; LAS Dated: September 1, 2003 Received: September 5, 2003
Dear Dr. Lin:
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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
10
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 Butman
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
11
Premarket Notification Supplement
Indications for Use Statement
KO32769 510(k) Number (if known): _
Device Name: Barbiturate Drug of Abuse Calibrators and Controls
Indications for Use:
The Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.
The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.
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)
Albert Cati
Division Sign-Off for Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032764
Page 2
12
Premarket Notification
Indications for Use Statement
510(k) Number (if known):
Device Name: Barbiturate Enzyme Immunoassay
Indications for Use:
The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.
The Barbiturate Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.
Albert Cill'\nDivision Sign-Off to. Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
Concurrence of CDRH, Office of
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)