(153 days)
Not Found
No
The device description and performance studies focus on a simple immunochromatographic test and its accuracy, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic (IVD) test for detecting methamphetamine in urine, which is used for screening purposes and not for treating or preventing a disease or condition.
Yes
The device is described as an "Immunoassay for the qualitative detection of methamphetamine in urine... For In vitro Diagnostic Use." This explicitly states its diagnostic purpose.
No
The device description explicitly states it is an "immunochromatographic test," which is a physical test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states "For In vitro Diagnostic Use" multiple times.
- Nature of the Test: The device is an immunoassay designed to detect a substance (methamphetamine) in a biological sample (urine) outside of the body. This is the definition of an in vitro diagnostic test.
- Purpose: The test is intended to "assist in screening of drugs of abuse samples," which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
Life Sign® Home Drug Test (MET) is designed for the qualitative detection of methamphetamine at the cutoff of 1000 ng/mL in urine to assist in screening of drugs of abuse samples at home or work place. For In vitro Diagnostic Use
Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 for ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use
Status Stik" MET is designed for the qualitative detection of methamphetamme at the cutoff of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic, Prescription Use.
Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
Product codes (comma separated list FDA assigned to the subject device)
MVO; DJC
Device Description
Life Sign® Home Drug Test (MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
Status Stik™ MET is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
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 (for LifeSign® Home Drug Test (MET)). Professional use via prescription (for Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET, AccuSign® MET, Status DSTM MET, AccuStrip™ MET).
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)
Substantial Equivalence: Life Sign® Home Drug Test (MET) is substantially equivalent to the K990786; Status DS ™ DOA 10. Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The detection cutoff level is the same. The tests demonstrate 100 % correlation when 94 specimens (50 negative and 44 positive) were compared. The difference is that Life Sign® Home Drug Test (MET) detects methamphetamine only, while Status DS " DOA 10 detects nine other drugs of abuse in addition to methamphetamine.
Consumer Study: In a consumer study, LifeSign® Home Drug Test (MET) showed over 96% overall accuracy.
Substantial Equivalence: Status Stik" MET is substantially equivalent to the K990786; Status DS™ DOA 10. Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The detection cutoff level is the same. The tests demonstrate 100 % correlation when 94 specimens (50 negative and 44 positive) were compared. The difference is that Status Stik™ MET detects methamphetamine only, while Status DS™ DOA 10 detects nine other drugs of abuse in addition to methamphetamine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100 % correlation when 94 specimens (50 negative and 44 positive) were compared; over 96% overall accuracy (consumer study data for LifeSign® Home Drug Test (MET)).
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
N/A
0
MAY 2 3 2002
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: K014 | 92
- Date of Summary: Dec. 13. 2001
Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 732-274-1010 FAX
Contact Person: Jemo Kang, Ph.D.
-
- Device Name: Trade Names: Life Sign® Home Drug Test(MET) Common or Usual Name: Immunoassay for detection of methamphetamine in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology
(91LAG for HPLC)
- Device Name: Trade Names: Life Sign® Home Drug Test(MET) Common or Usual Name: Immunoassay for detection of methamphetamine in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology
-
- Identification of legally marketed device to which claims equivalence: K990786; Status DS™ DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
-
- Device Description: Life Sign® Home Drug Test (MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
-
- Intended Use:Life Sign® Home Drug Test (MET) is designed for the qualitative detection of methamphetamine at the cutoff of 1000 ng/mL in urine to assist in screening of drugs of abuse samples at home or work place. For In vitro Diagnostic Use
-
- Substantial Equivalence: Life Sign® Home Drug Test (MET) is substantially equivalent to the K990786; Status DS ** DOA 10. Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The detection cutoff level is the same. The tests demonstrate 100 % correlation when 94 specimens (50 negative and 44 positive) were compared. The difference is that Life Sign® Home Drug Test (MET) detects methamphetamine only, while Status DS " DOA 10 detects nine other drugs of abuse in addition to methamphetamine.
-
- Consumer Study: In a consumer study, LifeSign® Home Drug Test (MET) showed over 96% overall accuracy.
-
Conclusion: The device is substantially equivalent to a legally marketed device K990786, Status DS™DOA 10 (MET/OPI/COC/THC/PCP/BZO/ BAR/MTD/TCA/AMP).
1
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: _ k O | 4192
-
- Date of Summary: Dec. 13, 2001
Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 732-274-1010 FAX
- Date of Summary: Dec. 13, 2001
Contact Person: Jemo Kang, Ph.D.
-
- Device Name: Trade Names: Stick Device: Status Stik" MET, AccuSign® Stik MET, AccuStik"" MET
Card Device: AccuSign® MET, Status DS " MET
- Device Name: Trade Names: Stick Device: Status Stik" MET, AccuSign® Stik MET, AccuStik"" MET
Strip Test: AccuStrip "" MET
Common or Usual Name: Immunoassay for detection of methamphetamine in
urine
Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91LAG for HPLC)
-
- Identification of legally marketed device to which claims equivalence: K990786; Status DS™ DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
-
- Device Description: Status Stik™ MET is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
-
- Intended Use: Status Stik" MET is designed for the qualitative detection of methamphetamme at the cutoff of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic, Prescription Use.
-
- Substantial Equivalence: Status Stik" MET is substantially equivalent to the K990786; Status DS™ DOA 10. Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The detection cutoff level is the same. The tests demonstrate 100 % correlation when 94 specimens (50 negative and 44 positive) were compared. The difference is that Status Stik™ MET detects methamphetamine only, while Status DS™ DOA 10 detects nine other drugs of abuse in addition to methamphetamine.
Conclusion: The device is substantially equivalent to a legally marketed device K990786, Status DS™ DOA 10 (MET/OPI/COC/THC/PCP/BZO/ BAR/MTD/TCA/AMP).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jemo Kang, Ph.D. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, NJ 08852-1905
Re: K014192
Trade/Device Name: LifeSign®Home Drug Test (MET) Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET, AccuSign® MET, Status DSTM MET, Strip: AccuStrip™ MET Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: MVO; DJC Dated: April 9, 2002 Received: April 10, 2002
MAY 2 3 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: LifeSign®Home Drug Test ( MET)
Indications For Use:
Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 for ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use
Page
Jean Cooger
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K014192
(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:_ (Per 21 CFR 801.109)
OR
Over The Counter Use: X
(Optional Format 1-2-96)
5
Page
of
K 814197 510(k) Number (if known):
Device Name: Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET, AccuSign® MET, Status DSTM MET, Strip: AccuStrip™ MET
Indications For Use:
Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
Trade Names for each format
Stick: Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET Card: AccuSign® MET, Status DSTM MET Strip: AccuStrip™ MET
Sean Coogler
(Division Sign Off)
Division of ...nical Laboratory r
510(k) Number K014192
(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)
OR
Over The Counter Use:
(Optional Format 1-2-96)