(79 days)
Not Found
No
The device description and intended use clearly define the product as calibrators and controls for drug assays, which are standard laboratory reagents and do not involve AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
This device is an in vitro diagnostic (IVD) product used for calibrating and monitoring assays for drugs of abuse. It does not treat or diagnose a disease in a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the calibrators and controls are "intended for in vitro diagnostic use." This indicates that they are used as part of a diagnostic process to measure analytes for medical purposes.
No
The device is described as liquid calibrators and controls containing known concentrations of drug analytes in a urine matrix. This is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the calibrators and controls "are intended for in vitro diagnostic use".
- Device Description: The device is a reagent (liquid calibrators and controls) used to calibrate and monitor the performance of assays for detecting drugs of abuse in urine, which is a biological sample.
- Intended User/Care Setting: The device is designed for "prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers," which are typical settings for in vitro diagnostic testing.
The entire context of the document describes a product used in a laboratory setting to perform diagnostic tests on patient samples (urine).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DKB, DIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use with homogeneous enzyme immunoassays on 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 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.
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
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 Materials
Class 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 Materials
Class 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 Controls
Page 1 of 9 |
| Classification Name: | Drug Mixture Calibrator Materials
Class 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 Materials
Class 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 Materials
Class 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 Materials
Class 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 |
1
Multi-calibrator Set B:
Previous Submission Information
There were no prior submissions for this subject device (K133710).
2
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:
| | Low
Calibrator
ng/mL | Cutoff
Calibrator
ng/mL | Intermediate
Calibrator
ng/mL | High
Calibrator
ng/mL | Control
Level 1
ng/mL | Control
Level 2
ng/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:
| | Low
Calibrator | Cutoff
Calibrator | Intermediate
Calibrator | High
Calibrator | Control
Level 1 | Control
Level 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
3
| | Low
Calibrator | Cutoff
Calibrator | Intermediate
Calibrator | High
Calibrator | Control
Level 1 | Control
Level 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
·
.
4
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.
5
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()
The LZI Multiple Set A, B, and C Dnies of Abuse Calibralors and Control (List Miller Andent (o them (o them (o them (o the 1) in the Ander (o the Milital )
Malye Set A Drugs
spiked values of calibrators and confirmed with GCMS. Performance chancecision, accuracy
sility are acceptable. The following able compacts LZI Multiple Analyte Set A, B, a
| Device
Characteristics | Subject Device
(K133710)
LZI Multiple Analyte
Set A
DAU Calibrators and Controls | Subject Device
(K133710)
LZI Multiple Analyte
Set B
DAU Calibrators and Controls | Subject Device
(K133710)
LZI Multiple Analyte
Set C
DAU Calibrators and Controls | Predicate Device
(K051088)
LZI Multiple Analyte DAU
Calibrators and Controls |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for in vitro diagnostic
use for the calibration and
validation of LZI DAU enzyme
immunoassays to detect
benzoylecgonine,
methamphetamine, methadone,
and 6-acetylmorphine, in
human urine.
The assays used with the multiple
analyte calibrators and controls only
provide a preliminary analytical result.
A more specific alternative chemical
method must be used in order to obtain
a confirmed analytical result. Gas or
liquid chromatography/mass
spectrometry (GC/MS or LC/MS) is
the preferred confirmatory method.
Clinical consideration and
professional judgment should be
exercised with any drug of abuse test
result, particularly when the | Intended for in vitro diagnostic
use for the calibration and
validation of LZI DAU enzyme
immunoassays to detect
MDMA, morphine, oxazepam,
and secobarbital in human
urine.
The assays used with the multiple
analyte calibrators and controls only
provide a preliminary analytical result.
A more specific alternative chemical
method must be used in order to obtain
a confirmed analytical result. Gas or
liquid chromatography/mass
spectrometry (GC/MS or LC/MS) is
the preferred confirmatory method.
Clinical consideration and
professional judgment should be
exercised with any drug of abuse test
result, particularly when the
preliminary test result is positive. | Intended for in vitro diagnostic
use for the calibration and
validation of LZI DAU enzyme
immunoassays to detect
benzoylecgonine,
methamphetamine, methadone,
morphine, oxazepam, and
secobarbital in human urine.
The assays used with the multiple
analyte calibrators and controls only
provide a preliminary analytical result.
A more specific alternative chemical
method must be used in order to obtain
a confirmed analytical result. Gas or
liquid chromatography/mass
spectrometry (GC/MS or LC/MS) is
the preferred confirmatory method.
Clinical consideration and
professional judgment should be
exercised with any drug of abuse test
result, particularly when the | Intended for in vitro diagnostic
use for the calibration and
validation of LZI DAU enzyme
immunoassays to detect
methamphetamine, opiate,
phencyclidine,
benzoylecgonine,
benzodiazepines, barbiturates,
methadone, and propoxyphene
in human urine. |
6
| Device
Characteristics | Subject Device
(K133710)
LZI Multiple Analyte
Set A
DAU Calibrators and Controls | Subject Device
(K133710)
LZI Multiple Analyte
Set B
DAU Calibrators and Controls | Subject Device
(K133710)
LZI Multiple Analyte
Set C
DAU Calibrators and Controls | Predicate Device
(K051088)
LZI Multiple Analyte DAU
Calibrators and Controls | | Low
Calibrator | Cutoff
Calibrator | Intermediate
Calibrator | High
Calibrator | Control
Level 1 | Control
Level 2 |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------|-------------------|----------------------|----------------------------|--------------------|--------------------|--------------------|
| Analyte | benzoylecgonine,
d-methamphetamine,
methadone,
6-acetylmorphine | morphine,
oxazepam,
secobarbital,
MDMA | benzoylecgonine
d-methamphetamine,
methadone,
morphine,
oxazepam,
secobarbital | benzoylecgonine,
d-methamphetamine,
methadone,
morphine,
oxazepam,
secobarbital,
phencyclidine,
propoxyphene | ng/mL | 250 | 500 | 750 | 1000 | 375 | 625 |
| Materials are
applicable for assays
with the cutoff
concentrations listed
(ng/mL) | COC - 150
MAMP or AMP - 500
MTD - 300
6AM - 10 | OPI - 2,000
BZO - 200
BARB - 200
MDMA - 500 | COC - 150
MAMP or AMP - 500
MTD - 300
OPI - 2,000
BZO - 200
BARB - 200 | COC - 150
MAMP or AMP - 500
MTD - 300
OPI - 2,000
BZO - 200
BARB - 200
PCP - 25
PPX - 300 | ng/mL | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Matrix | Urine | Urine | Urine | Urine | | | | | | | |
| Calibrators Level | 5 Levels - See Table 1
(under "Device
Description") | 5 Levels - See Table 2
(under "Device
Description") | 5 Levels - See Table 3
(under "Device
Description") | 5 Levels - See Table 4
(below) | | | | | | | |
| Controls Level | 2 Levels - See Table 1
(under "Device
Description") | 2 Levels - See Table 2
(under "Device
Description") | 2 Levels - See Table 3
(under "Device
Description") | 2 Levels - See Table 4
(below) | | | | | | | |
| Storage | 2-8 °C until expiration
date | 2-8 °C until expiration
date | 2-8 °C until expiration
date | 2-8 °C until expiration
date | | | | | | | |
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.
9
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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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