(301 days)
Not Found
No
The device description and intended use clearly state that it is a simple one-step immunochromatographic test, which is a standard biochemical assay method and does not involve AI/ML. There are no mentions of AI, ML, or image processing in the summary.
No
This device is for in vitro diagnostic use, specifically for screening drugs of abuse, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro Diagnostic Use" multiple times, and the purpose is to detect various drug metabolites to assist in screening for drugs of abuse.
No
The device description explicitly states it is an "immunochromatographic test," which is a physical test strip or device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statements explicitly state "For in vitro Diagnostic Use" multiple times across all variations of the device description. This is the primary indicator that the device is intended for use outside of the body to examine specimens for diagnostic purposes.
Furthermore, the device description details an "immunochromatographic test for the rapid, qualitative, simultaneous detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine". Testing urine samples to detect substances is a common application of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse samples. For in vitro Diagnostic Use. The detection cutoff concentrations are as follows:
THC: 11-nor-Δ⁹-THC-9-carboxylic acid, 50 ng/mL
OPI: Morphine, 2000 ng/mL
COC: Benzoylecgonine, 300 ng/mL
MET: D-Methamphetamine, 500 ng/mL
MDMA: 3,4-methylenedioxymethamphetamine, 500 ng/mL
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
Product codes
LAF, LDJ, DJG, DIO
Device Description
Status Stik™ THC/OPI/COC/MET & MDMA is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, methamphetamine and 3,4-methylenedioxymethamphetamine.
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
Home or work place
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)
In a consumer study, LifeSign® Home Drug Test (THC/OPI/ COC/ MET) showed over 95% overall accuracy. Since LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy) is the same test (principle, format, test protocol, the reading of test result etc.) except the antibody used for methamphetamine, no new consumer study was performed.
In a consumer study, LifeSign® Home Drug Test (MET) showed over 96% overall accuracy. Since LifeSign® Home Drug Test (Ecstasy & MET) is the same test (principle, format, test protocol, the reading of test result etc.) except the antibody used for methamphetamine, no new consumer study was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is: Ko223837
Date of Summary: Nov. 14, 2002 1.
-
- Submitted by: Princeton BioMeditech Corporation
4242 U.S. Route 1, Monmouth Jct., NJ 08852
- Submitted by: Princeton BioMeditech Corporation
PHONE 732-274-1000
FAX 732-274-1010
Contact Person: Jemo Kang, Ph.D., Director
- Device Name
Trade Names: Stick: Status Stik™ THC/OPI/COC/MET & MDMA, AccuSign Stik THC/OPI/COC/MET & MDMA, AccuStik™ DOA4 Card: AccuSign® DOA4, Status DSTM DOA4
Strip: AccuStrip™ DOA4
Common or Usual Name: Immunoassay for detection of THC, opiates, cocaine, and methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA) in urine
Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DJG, 91DIO for Enzyme Immunoassay, 91LAG for HPLC)
-
- Identification of legally marketed device to which claims equivalence: Status Stik™ THC/OPI/COC/MET; K014193
-
- Device Description: Status Stik™ THC/OPV/COC/MET & MDMA is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, methamphetamine and 3,4-methylenedioxymethamph- etamine.
-
- Intended Use: Status Stik™ THC/OPI/COC/MET & MDMA is designed for the qualitative detection of THC at the cutoff of 50 ng/mL 11-nor-A-THC-9-carboxylic acid. opiates at the cutoff of 2000 ng/mL morphine, cocaine at the cutoff of 300 ng/mL benzoylecgonine, and methamphetamine and MDMA at the cutoff of 500 ng/mL d-methamphetamine and MDMA in human urine to assist in screening of drugs of abuse samples. For in vitro Diagnostic Use. This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
-
- Substantial Equivalence: Status Stik™ THC/OPI/COC/MET & MDMA is substantially equivalent to the K014193. Status Stik™ THC/OPI/COC/MET. Both products use the same assay principle and are immunochromatographic assays to detect THC, opiates, cocaine, methamphetamine qualitatively. The difference is that Status Stik™ THC/OPI/COC/MET detects methamphetamine at 1000 ng/mL and MDMA at 2000 ng/mL, while Status StikTM THC/OPI/COC/MET & MDMA detects both methamphetamine and MDMA at 500 ng/mL.
- Conclusion: The device is substantially equivalent to the legally marketed device, K014193, Status Stik™ THC/OPI/COC/MET.
1
510(k) Summarv
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is:
-
- Date of Summary: Nov 15. 2002
- Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010
Contact Person: Jemo Kang, Ph.D., Director
-
- Device Name
Trade Names: LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) Common or Usual Name: Immunoassay for detection of THC, opiates, cocaine,
- Device Name
methamphetamine and 3,4-methlyenedioxymethamphetamine (MDMA) in urine
Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DJG, 91DIO for Enzyme Immunoassay, 91LAG for HPLC)
-
- Identification of legally marketed device to which claims equivalence: LifeSign® Home Drug Test (THC/OPI/COC/MET): K014193
-
- Device Description: LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, methamphetamine, and 3,4-methylenedioxymethamphetamine.
-
- Intended Use: LifeSign® Home Drug Test is designed for the qualitative detection of THC at the cutoff of 50 ng/mL 11-nor-d'-THC-9-carboxvlic acid, opiates at the cutoff of 2000 ng/mL morphine, cocaine at the cutoff of 300 ng/mL benzoylecgonine, methamphetamine and MDMA at the cutoff of 500 ng/mL d-methamphetamine and MDMA in human urine to assist in screening of drugs of abuse samples. For in vitro Diagnostic Use. This test is intended for use in the home to assist in preventing drug abuse.
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
-
- Substantial Equivalence: LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy) is substantially equivalent to to the K014193, LifeSign® Home -Drug Test (THC/OPI/COC/MET). Both products use the same assay principle and are immunochromatographic assays to detect THC, opiates, cocaine, methamphetamine qualitatively. The difference is that LifeSign® Home Drug Test (THC/OPI/COC/MET) detects methamphetamine at 1000 ng/mL and MDMA at 2000 ng/mL, while LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & & MET) detects both methamphetamine and MDMA at 500 ng/mL.
2
-
- Consumer Study: In a consumer study, LifeSign® Home Drug Test (THC/OPI/ COC/ MET) showed over 95% overall accuracy. Since LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy) is the same test (principle, format, test protocol, the reading of test result etc.) except the antibody used for methamphetamine, no new consumer study was performed.
- Conclusion: The device is substantially equivalent to the legally marketed device, K014193, LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET). The product is safe in the hands of the lay user.
3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is:_ につつる8 37
- Date of Summary: Nov. 14, 2002
-
Princeton BioMeditech Corporation 2. Submitted by:
4242 U.S. Route 1. Monmouth Jct., NJ 08852 -
PHONE 732-274-1000
FAX 732-274-1010
Contact Person: Jemo Kang, Ph.D.
-
- Device Name: Trade Names: Stick Device: Status Stik™ MET & MDMA, AccuSign® Stik MET & MDMA, AccuStik" MET & MDMA
Card Device: AccuSign® MET & MDMA, Status DS™ MET & MDMA
- Device Name: Trade Names: Stick Device: Status Stik™ MET & MDMA, AccuSign® Stik MET & MDMA, AccuStik" MET & MDMA
Strip Test: AccuStrip™ MET & MDMA
Common or Usual Name: Immunoassay for detection of methamphetamine
and 3,4-Methylenedioxymethamphetamine
(MDMA) in urine
Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91LAG for HPLC)
-
- Identification of legally marketed device to which claims equivalence: K014092;
Status Stik™ MET
- Identification of legally marketed device to which claims equivalence: K014092;
-
- Device Description: Status Stik" MET & MDMA is simple one step immunochromatographic test for the rapid, qualitative detection methamphetamine and MDMA.
-
- Intended Use: Status Stik""MET & MDMA is designed for the qualitative detection of both methamphetamine and MDMA at the cutoff of 500 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic, Prescription Use. This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
-
- Substantial Equivalence: Status Stik™ MET & MDMA is substantially equivalent to the K014092, Status Stik™ MET. Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The difference is that Status Stik"" MET detects methamphetamine at 1000 ng/ml and MDMA at 2000 ng/ml, while Status DS™ MET & MDMA detects both methamphetamine and MDMA at 500 ng/ml.
Conclusion: The device is substantially equivalent to a legally marketed device K014092,
4
510(k) Summarv
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is: 16023832
-
- Date of Summary: Nov. 14, 2002
-
- Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010 Contact Person: Jemo Kang, Ph.D.
-
- Device Name: Trade Names: Life Sign® Home Drug Test (Ecstasy & MET) Common or Usual Name: Immunoassay for detection of methamphetamine and methylenedioxymethamphetamine (MDMA) in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91LAG for HPLC)
-
- Identification of legally marketed device to which claims equivalence: K014192 Life Sign® Home Drug Test (MET)
-
- Device Description: Life Sign® Home Drug Test (Ecstasy & MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine and MDMA.
- Intended Use: Life Sign® Home Drug Test (Ecstasy & MET) is designed for the 6. qualitative detection of MDMA and methamphetamine at the cutoff of 500 ng/mL in urine to assist in screening of drugs of abuse samples at home or work place. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
- Substantial Equivalence: Life Sign® Home Drug Test (Ecstasy & MET) is substantially 7. equivalent to the k0140192; Life Sign® Home Drug Test (MET). Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The difference is that Life Sign® Home Drug Test (MET) detects methamphetamine at 1000 ng/ml and MDMA at 2000 ng/ml, while Life Sign® Home Drug Test (Ecstasy & MET) detects both methamphetamine and MDMA at 500 ng/ml.
-
- Consumer Study: In a consumer study, LifeSign® Home Drug Test (MET) showed over 96% overall accuracy. Since LifeSign® Home Drug Test (Ecstasy & MET) is the same test (principle, format, test protocol, the reading of test result etc.) except the antibody used for methamphetamine, no new consumer study was performed.
- Conclusion: The device is substantially equivalent to a legally marketed device k0140192, LifeSign® Home Drug Test (MET).
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a wavy base. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jemo Kang, Ph.D., M.B.A. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, NJ 08852-1905
Re: K023837
Trade/Device Name: Status Stik™ THC/OPI/COC/MET & MDMA, AccuSign® Stik THC/OPI/COC/MET & MDMA, AccuStik® DOA 4, Status DSTM DOA 4, AccuSign® DOA 4, AccuStripTM DOA 4 Status Stik™ MET & MDMA, AccuSign® Stik MET & MDMA, AccuStik® MET & MDMA, AccuSign® MET & MDMA, Status DSTM MET & MDMA, AccuStrip™ MET & MDMA LifeSign®Home Drug Test (Ecstasy/MET) LifeSign Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) Regulation Number: - 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF; LDJ; DJG; DIO Dated: June 19, 2003 Received: June 19, 2003
SEP 1 5 2003
Dear Dr. Kang:
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.
6
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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 Sutman
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
7
Page Page 2 of
510(k) Number (if known):
Device Name: Status Stik™ MET & MDMA, AccuSign®Stik MET & MDMA, AccuStik™ MET & MDMA, AccuSign® MET & MDMA, Status DS™ MET & MDMA, AccuStrip™ MET & MDMA
Indications For Use:
Immunoassay for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
Trade Names for each format
Stick: Status Stik™ MET & MDMA, AccuSign®Stik MET & MDMA, AccuStik™ MET & MDMA Card: AccuSign® MET & MDMA, Status DS™ MET & MDMA Strip: AccuStrip™ MET & MDMA
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| Professional Use: | |
|---|---|
| Prescription Use: | X |
| (Per 21 CFR 801.109) |
Division Sign-Off for Jean Cooper
Office of In Vitro Di 4
ffice of In Vitro Diagnostic Device ( Evaluation and Safety
510(k) K023837
Over The Counter Use: __
(Optional Format 1-2-96)
8
Page of
14023837
Device Name: Status Stik™ THC/OPI/COC/MET & MDMA, AccuSign® Stik THC/OPI/COC/MET & MDMA, AccuStik®DOA 4, Status DS™ DOA 4, AccuSign® DOA 4
Indications For Use:
510(k) Number (if known):
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse. For in vitro Diagnostic Use The detection cutoff concentrations are as follows:
| THC | 11-nor-Δ 9-THC-9-carboxylic acid | 50 ng/ mL |
|---|---|---|
| OPI | Morphine | 2000 ng/ mL |
| COC | Benzoylecgonine | 300 ng/ mL |
| MET | D-Methamphetamine | 500 ng/ mL |
| MDMA | 3,4-Methylenedioxymethamphetamine | 500 ng/ mL |
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
Trade Names for each device format
Stick: Status Stik™ THC/OPI/COC/MET & MDMA, AccuSign®Stik THC/OPI/COC/MET & MDMA, AccuStik™ DOA4 Card: AccuSign® DOA4, Status DSTM DOA4
Strip: AccuStrip™ DOA4
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
4
Professional Use:
Prescription Use: X
OR
Over The Counter Use:
(Per 21 CFR 801.109)
Albert
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K023837
(Optional Format 1-2-96)
9
Page of
510(k) Number (if known): Ko23837
Device Name:_ LifeSign®Home Drug Test ( Ecstasy/MET)
Indications For Use:
the the qualitative detection of methamphetamine Immunoassay for and 3,4methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use: __
Prescription Use:__ OR
(Per 21 CFR 801.109)
Division Sign-Off for Jean Cooper
Office of In Vitro Diagnostic Device 5 Evaluation and Safety
Over The Counter Use: X
(Optional Format 1-2-96)
510(k) K023837
10
Page of
510(k) Number (if known):
Device Name: LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET)
Indications for Use:
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse samples at home or work places. For in vitro Diagnostic Use. The detection cutoff concentrations are as follows:
| THC | 11-nor-Δ⁹-THC-9-carboxylic acid | 50 ng/mL |
|---|---|---|
| OPI | Morphine | 2000 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| MET | D-Methamphetamine | 500 ng/mL |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 ng/mL |
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:_
Prescription Use:
OR
Over The Counter Use: X
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k0209837
5