(79 days)
The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphelamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepan, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.
The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphelamine, Methadone, 6-acetylmorphine, Oxazepan, and Secobarbital. The controls are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.
All of the LZI Multiple Analyte Set A, B, and C Drugs of Abuse Calibrators and Controls are 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 as a mixture.
The Negative DAU Calibrator is a processed, drug-free human urine matrix in human urine with sodium azide (0.09%) as preservative. 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. These five calibrators and two controls are sold as individual bottles.
Acceptance Criteria and Device Performance Study
This document describes the acceptance criteria and study proving the performance of the LZI Multiple Analyte Set A, B, and C Drugs of Abuse Calibrators and Controls. These devices are intended for in vitro diagnostic use for the calibration and monitoring of homogeneous enzyme immunoassays for drugs of abuse in human urine.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated based on stability, traceability, and value assignment, with the primary acceptance criteria being that the calibrators and controls should not vary by more than ±10% in stability studies and that assigned values are within ±10% of target concentrations.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Stability | Not vary greater than ±10% in individual concentration or total separation for Cold (2-8 ℃), Room Temperature, and Accelerated (30 ℃) Temperature studies. |
| Traceability and Value Assignment | Verified by GC/MS to be within ± 10% of the target concentration. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size" for a test set in the traditional sense of patient samples. Instead, the testing involved:
- Stability Studies: Measurements were taken on various calibrator and control sets at multiple temperatures (Cold: 2-8 ℃, Room Temperature, Accelerated: 30 ℃) over a period up to Day 366. The number of individual vials or replicates per concentration for these studies is not specified, but it covered all analytes across Sets A, B, and C.
- Traceability and Value Assignment: This involved
- One commercial standard stock solution per analyte (purity 99%, verified by GC/MS).
- Secondary stock solutions (concentration verified gravimetrically).
- Final calibrator and control products (prepared by spiking into negative urine matrix and verified by GC/MS). The exact number of individual samples for the GC/MS verification is not detailed.
Data Provenance: The study appears to be an internal laboratory study conducted by Lin-Zhi International, Inc. given the context of a 510(k) submission. The data is prospective, generated specifically for this submission to demonstrate substantial equivalence. The country of origin of the data is implicitly the USA, where the company is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (calibrators and controls for in vitro diagnostics) does not rely on human expert interpretation or ground truth in the way medical imaging or clinical diagnostic devices would. Instead:
- Ground Truth (Reference Values): The "ground truth" for the calibrators and controls is established by the precisely known concentrations of drug analytes spiked into the negative urine matrix. These concentrations are analytically verified.
- Verification Method: Gas Chromatography/Mass Spectrometry (GC/MS) is cited as the method for verifying the purity of starting materials and the final concentrations in the calibrators/controls. GC/MS is a highly accurate and widely accepted analytical technique for confirming the presence and concentration of substances.
Therefore, no clinical experts (e.g., radiologists) were used. The "experts" in this context would be analytical chemists or lab personnel skilled in performing and interpreting GC/MS results and gravimetric measurements. Their specific qualifications are not detailed, but their work is grounded in established analytical chemistry principles.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is analytically determined by precise spiking and confirmed by GC/MS, not by human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not applicable to this device. This device is a set of calibrators and controls used to standardize and monitor automated laboratory assays, not an AI or diagnostic tool that involves human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "performance" being evaluated is the chemical and physical characteristics of the calibrators and controls themselves (stability, accurate concentration). This evaluation is inherently "standalone" in that it assesses the product's intrinsic properties through analytical methods (spectrometry, gravimetry) without human intervention in the result generation or interpretation of a diagnostic outcome. The calibrators/controls are not an "algorithm," but their performance is objectively measured.
7. The Type of Ground Truth Used
The ground truth used is based on analytical confirmation of spiked concentrations using:
- Gravimetrically prepared concentrations: The known amounts of drug analyte spiked into the urine matrix.
- Mass Spectrometry (GC/MS): An independent analytical method used to verify the purity of starting materials and the final concentrations in the calibrators and controls to ensure they are within ±10% of the target concentration.
This is a form of highly precise reference standard or chemical assay ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a set of calibrators and controls, not an AI/machine learning algorithm that requires a "training set." Its performance is based on its chemical manufacturing and analytical verification, not on learning from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, there is no training set for this type of device.
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FEB 2 1 2014
k133,710
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. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849 · e-mail: bclin@lin-zhi.com
Contact: Bernice Lin. Ph.D. VP Operations
Submission Date
February 21, 2014
Multi-calibrator Set A, B, and C Device Name and Classification
Multi-calibrator Set A:
| Classification Name: | Drug Mixture Calibrator MaterialsClass II, DKB (91 Toxicology)21 CFR862.3200 |
|---|---|
| Common Name: | Benzoylecgonine, Methamphetamine, Methadone, and 6-acetylmorphine Calibrators |
| Proprietary Name: | LZI Multiple Analyte Set A Drugs of Abuse Calibrators |
| Classification Name: | Drug Mixture Control MaterialsClass I, DIF (91 Toxicology),21 CFR 862.3280 |
| Common Name: | Benzoylecgonine, Methamphetamine, Methadone, and 6-acetylmorphine Controls |
| Proprietary Name: | LZI Multiple Analyte Set A Drugs of Abuse ControlsPage 1 of 9 |
| Classification Name: | Drug Mixture Calibrator MaterialsClass II, DKB (91 Toxicology),21 CFR862.3200 |
| Common Name: | MDMA, Morphine, Oxazepam, and Secobarbital Calibrators |
| Proprietary Name: | LZI Multiple Analyte Set B Drugs of Abuse Calibrators |
| Classification Name: | Drug Mixture Control MaterialsClass I, DIF (91 Toxicology),21 CFR 862.3280 |
| Common Name: | MDMA, Morphine, Oxazepam, and Secobarbital Controls |
| Proprietary Name: | LZI Multiple Analyte Set B Drugs of Abuse Controls |
| Multi-calibrator Set C: | |
| Classification Name: | Drug Mixture Calibrator MaterialsClass II, DKB (91 Toxicology),21 CFR862.3200 |
| Common Name: | Benzoylecgonine, Methamphetamine, Methadone, Morphine,Oxazepam, and Secobarbital Calibrators |
| Proprietary Name: | LZI Multiple Analyte Set C Drugs of Abuse Calibrators |
| Classification Name: | Drug Mixture Control MaterialsClass I, DIF (91 Toxicology),21 CFR 862.3280 |
| Common Name: | Benzoylecgonine, Methamphetamine, Methadone, Morphine,Oxazepam, and Secobarbital Controls |
| Proprietary Name: | LZI Multiple Analyte Set C Drugs of Abuse Controls |
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Multi-calibrator Set B:
Previous Submission Information
There were no prior submissions for this subject device (K133710).
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Legally Marketed Predicate Device(s)
The LZI Multiple Analyte Set A. B. and C Drugs of Abusc Calibrators and Controls (K133710) are substantially equivalent to the Multiple Analyte Drugs of Abuse Calibrators and Controls (K051088) manufactured by Lin-Zhi International, Inc. The LZI Multiple Analyte Set A. B. and C Drugs of Abuse Calibrators and Controls are identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance. ·
Device Description
All of the LZI Multiple Analyte Set A, B, and C Drugs of Abuse Calibrators and Controls are 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 as a mixture.
The Negative DAU Calibrator is a processed, drug-free human urine matrix in human urine with sodium azide (0.09%) as preservative. 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. These five calibrators and two controls are sold as individual bottles. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:
| LowCalibratorng/mL | CutoffCalibratorng/mL | IntermediateCalibratorng/mL | HighCalibratorng/mL | ControlLevel 1ng/mL | ControlLevel 2ng/mL | |
|---|---|---|---|---|---|---|
| Material | ||||||
| Benzoylecgonine | 75 | 150 | 300 | 1000 | 112.5 | 187.5 |
| d-Methamphetamine | 250 | 500 | 750 | 1000 | 375 | 625 |
| Methadone | 150 | 300 | 600 | 1000 | 225 | 375 |
| 6-AM | 5 | 10 | 20 | 40 | 7.5 | 12.5 |
Table 1: LZI Multiple Analyte Set A Calibrators and Controls:
- 5" Calibrator is the Negative Calibrator
Table 2: LZI Multiple Analyte Set B Calibrators and Controls:
| LowCalibrator | CutoffCalibrator | IntermediateCalibrator | HighCalibrator | ControlLevel 1 | ControlLevel 2 | |
|---|---|---|---|---|---|---|
| Material | ng/mL | ng/mL | ng/mL | ng/mL | ng/mL | ng/mL |
| MDMA | 250 | 500 | 750 | 1000 | 375 | 625 |
| Morphine | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Oxazepam | 100 | 200 | 500 | 1000 | 150 | 250 |
| Secobarbital | 100 | 200 | 500 | 1000 | 150 | 250 |
- 5th Calibrator is the Negative Calibrator
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| LowCalibrator | CutoffCalibrator | IntermediateCalibrator | HighCalibrator | ControlLevel 1 | ControlLevel 2 | |
|---|---|---|---|---|---|---|
| Material | ng/mL | ng/mL | ng/mL | ng/mL | ng/mL | ng/mL |
| Benzoylecgonine | 75 | 150 | 300 | 1000 | 112.5 | 187.5 |
| d-Methamphetamine | 250 | 500 | 750 | 1000 | 375 | 625 |
| Methadone | 150 | 300 | 600 | 1000 | 225 | 375 |
| Morphine | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Oxazepam | 100 | 200 | 500 | 1000 | 150 | 250 |
| Secobarbital | 100 | 200 | 500 | 1000 | 150 | 250 |
Table 3: LZI Multiple Analyte Set C Calibrators and Controls:
- 5th Calibrator is the Negative Calibrator
·
.
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Intended Use
Device Name: LZI Multiple Analyte Set A, B, and C Urine Drugs of Abusc Calibrators
The LZI Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of assavs for the analytes currently listed in the package insert: Benzovlecgonine. Methamphetamine, Methadone. 6-acetylmorphine, MDMA, Morphine. Oxazepam, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassavs on automated clinical chemistry analyzers.
Device Name: LZI Multiple Analyte Set A. B. and C Urine Drugs of Abuse Controls
The LZI Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzovlecgonine. Methamphetamine. Methadone. 6-acctylmorphine. MDMA, Morphine, Oxazepam, and Secobarbital. The controls are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.
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| DeviceCharacteristics | Subject Device(K133710)LZI Multiple AnalyteSet ADAU Calibrators and Controls | Subject Device(K133710)LZI Multiple AnalyteSet BDAU Calibrators and Controls | Subject Device(K133710)LZI Multiple AnalyteSet CDAU Calibrators and Controls | Predicate Device(K051088)LZI Multiple Analyte DAUCalibrators and Controls |
|---|---|---|---|---|
| Intended Use | Intended for in vitro diagnosticuse for the calibration andvalidation of LZI DAU enzymeimmunoassays to detectbenzoylecgonine,methamphetamine, methadone,and 6-acetylmorphine, inhuman urine.The assays used with the multipleanalyte calibrators and controls onlyprovide a preliminary analytical result.A more specific alternative chemicalmethod must be used in order to obtaina confirmed analytical result. Gas orliquid chromatography/massspectrometry (GC/MS or LC/MS) isthe preferred confirmatory method.Clinical consideration andprofessional judgment should beexercised with any drug of abuse testresult, particularly when the | Intended for in vitro diagnosticuse for the calibration andvalidation of LZI DAU enzymeimmunoassays to detectMDMA, morphine, oxazepam,and secobarbital in humanurine.The assays used with the multipleanalyte calibrators and controls onlyprovide a preliminary analytical result.A more specific alternative chemicalmethod must be used in order to obtaina confirmed analytical result. Gas orliquid chromatography/massspectrometry (GC/MS or LC/MS) isthe preferred confirmatory method.Clinical consideration andprofessional judgment should beexercised with any drug of abuse testresult, particularly when thepreliminary test result is positive. | Intended for in vitro diagnosticuse for the calibration andvalidation of LZI DAU enzymeimmunoassays to detectbenzoylecgonine,methamphetamine, methadone,morphine, oxazepam, andsecobarbital in human urine.The assays used with the multipleanalyte calibrators and controls onlyprovide a preliminary analytical result.A more specific alternative chemicalmethod must be used in order to obtaina confirmed analytical result. Gas orliquid chromatography/massspectrometry (GC/MS or LC/MS) isthe preferred confirmatory method.Clinical consideration andprofessional judgment should beexercised with any drug of abuse testresult, particularly when the | Intended for in vitro diagnosticuse for the calibration andvalidation of LZI DAU enzymeimmunoassays to detectmethamphetamine, opiate,phencyclidine,benzoylecgonine,benzodiazepines, barbiturates,methadone, and propoxyphenein human urine. |
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| DeviceCharacteristics | Subject Device(K133710)LZI Multiple AnalyteSet ADAU Calibrators and Controls | Subject Device(K133710)LZI Multiple AnalyteSet BDAU Calibrators and Controls | Subject Device(K133710)LZI Multiple AnalyteSet CDAU Calibrators and Controls | Predicate Device(K051088)LZI Multiple Analyte DAUCalibrators and Controls | LowCalibrator | CutoffCalibrator | IntermediateCalibrator | HighCalibrator | ControlLevel 1 | ControlLevel 2 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyte | benzoylecgonine,d-methamphetamine,methadone,6-acetylmorphine | morphine,oxazepam,secobarbital,MDMA | benzoylecgonined-methamphetamine,methadone,morphine,oxazepam,secobarbital | benzoylecgonine,d-methamphetamine,methadone,morphine,oxazepam,secobarbital,phencyclidine,propoxyphene | ng/mL | 250 | 500 | 750 | 1000 | 375 | 625 |
| Materials areapplicable for assayswith the cutoffconcentrations listed(ng/mL) | COC - 150MAMP or AMP - 500MTD - 3006AM - 10 | OPI - 2,000BZO - 200BARB - 200MDMA - 500 | COC - 150MAMP or AMP - 500MTD - 300OPI - 2,000BZO - 200BARB - 200 | COC - 150MAMP or AMP - 500MTD - 300OPI - 2,000BZO - 200BARB - 200PCP - 25PPX - 300 | ng/mL | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Matrix | Urine | Urine | Urine | Urine | |||||||
| Calibrators Level | 5 Levels - See Table 1(under "DeviceDescription") | 5 Levels - See Table 2(under "DeviceDescription") | 5 Levels - See Table 3(under "DeviceDescription") | 5 Levels - See Table 4(below) | |||||||
| Controls Level | 2 Levels - See Table 1(under "DeviceDescription") | 2 Levels - See Table 2(under "DeviceDescription") | 2 Levels - See Table 3(under "DeviceDescription") | 2 Levels - See Table 4(below) | |||||||
| Storage | 2-8 °C until expirationdate | 2-8 °C until expirationdate | 2-8 °C until expirationdate | 2-8 °C until expirationdate |
Comparison to Predicate Device (continued
Page 7 of 9
{7}------------------------------------------------
:
Table 4: Predicate Multiple Analyte Calibrators and Controls (K051088)
5" Calibrator is the Negative Calibrator
,
.
{8}------------------------------------------------
Performance Characteristics Summary:
Multiple Analyte Sets A,B, and C Drugs of Abuse Calibrators and Controls Stability:
Based on the largest % change for any individual concentration or % change in Total Separation (versus Day 0 measurements) at Cold (2-8 ℃), Room Temperature, and Accelerated (30 ℃) Temperature sudies, the LZ1 Multiple Analyte Set A. B. and C Drugs of Abuse Calibrators and Controls did not vary greater than ±10%. In Set A. the only analyte for which this differed was the 6- acetylmorphine (6AM) Calibrator and Control. In Set B and C. the only analyte for which this differed was the Benzodiazeoine (Oxazepam) Calibrator and Control. All calibrators and controls held steady when stored at 2 ℃ to 8 ℃ (refrigerated) up to Day 366 real time. Based on these data we have capped our predicted shelf-life to the current cold temperature real-time study for the LZI Multiple Analyte Sets A. B. and C Drugs of Abuse Calibrators and Controls to at least 12 months.
Traceability and Value Assignment:
The starting materials for the calibrators and controls were commercially available standard stock solutions in methanol. The standard solution was found to be 99% in purity, analvzed by GC/MS, Secondary stock solutions were prepared using negative urine calibrator matrix and the concentrations were verified gravimetrically using balances calibrated with NIST traceable weights. The secondary stock solutions were then spiked into the negative urine calibrator matrix to the desired concentration and verified by GC/MS to be within ± 10% of the uarget concentration.
Summary:
The information provided in this pre-market notification demonstrates that the LZJ Multiple Analyte Sets A. B. and C Drugs of Abuse Calibrators and Controls are substantially equivalent to the legally marketed predicate device for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by gas chromatography/mass spectrometry (GC/MS), an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Multiple Analyte Sets A, B, and C Drugs of Abuse Calibrators and Controls are safe and cflective for its stated intended use.
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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle of text that reads "Department of Health & Human Services USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO64-(isa) Silver Spong, MI) 20043-00002
February 21, 2014
LIN-ZHI INTERNATIONAL, INC. BERNICE LIN, PH.D. VP OPERATIONS 670 ALMANOR AVE SUNNYVALE CA 94085
Received: December 4, 2013
Re: K133710
Trade/Device Name: Lin-Zhi Multiple Analyte Set A. B and C Urine Drugs of Abuse Calibrators Lin-Zhi Multiple Analyte Set A. B and C Urine Drugs of Abuse Controls Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: II Product Code: DKB, DIF Dated: December 2, 2013
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 dute 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 fiability 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 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 (QS) regulation (21 CFR Part 820); and if applicable. the
{10}------------------------------------------------
Page 2-Ms Lin
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 regulations (21 CFR Parts 80) and 809), please contact 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/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 805), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 hup://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Ruth A. Chesler -S
lior
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
{11}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133710
Device Name
Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Callbrators; Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls
Indications for Use (Describe)
The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in viro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphelamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepan, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.
The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphelamine, Methadone, 6-acetylmorphine, Oxazepan, and Secobarbital. The controls are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 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.