(173 days)
Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. Status DS ™ Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use. The Status DSTM Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.
Status DS'" Nicotine is a simple one step immunochromatographic test for the rapid, qualitative detection of cotinine, a major metabolite of nicotine.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document describes a qualitative immunoassay for cotinine detection to screen for nicotine exposure. The primary study presented is a substantial equivalence comparison to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative Detection of Cotinine at 500 ng/mL Cutoff | 100% correlation with predicate device (K972481; Auto-Lyte Cotinine EIA) |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: 94 specimens (50 negative and 44 positive).
- Data Provenance: Not explicitly stated, but common for such studies to use clinical samples. No information on country of origin or if it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study does not establish ground truth using human experts. Instead, it compares the new device's results to those of a legally marketed predicate device (K972481; Auto-Lyte Cotinine EIA).
4. Adjudication method for the test set:
- Not applicable, as the 'ground truth' was based on the predicate device's results, not a consensus among human reviewers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a standalone diagnostic test, not an AI-assisted interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the device. The 100% correlation found was the device's performance compared to a predicate device, without human intervention in the interpretation process described in the study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study was the results obtained from a legally marketed predicate device, the Auto-Lyte Cotinine EIA (K972481).
8. The sample size for the training set:
- Not applicable. This device is an immunoassay, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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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:
Date of Summary: August 28, 2006
Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1. Monmouth Jct., NJ 08852 PHONE 732-274-1000 732-274-1010 FAX
- Device Name: Trade Names: Status DS " Nicotine, AccuSign® Nicotine Common or Usual Name: Immunoassay for detection of cotinine, metabolite of nicotine in urine Classification Name: Carbon monoxide test system (21CFR862.3220, Product Code: MKU)
-
- Identification of legally marketed device to which claims equivalence: K972481; Auto-Lyte Cotinine EIA
-
- Device Description: Status DS'" Nicotine is a simple one step immunochromatographic test for the rapid, qualitative detection of cotinine, a major metabolite of nicotine.
-
Intended Use: Status DS™Nicotine is designed for the qualitative detection of cotinine at the cutoff of 500 ng/mL in urine to assist in screening for exposure to nicotine. For In vitro Diagnostic, Professional Use. The Status DS™ Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.
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Substantial Equivalence: Status DS™ Nicotine is substantially equivalent to the K972481; Auto-Lyte Cotinine EIA manufactured by Orasure Technologies, Inc. Status DS' Nicotine is a qualitative test and Auto-Lyte Cotinine EIA is a qualitative and semiquantitative test. Both tests detect cotinine in human urine at the cutoff level of 500 ng/mL. The tests demonstrated 100 % correlation when 94 specimens (50 negative and 44 positive) were compared.
Conclusion: The device is substantially equivalent to a legally marketed device K972481, Auto-Lyte Cotinine EIA
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kyung-Ah Kim Princeton Biomeditech Corp. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852-1905 US
FEB 2 0 2007
Re: K062565
Trade/Device Name: Status DS Nicotine, Accusign Nicotine, Biosign Nicotine Regulation Number: 21 CFR 862.3220 Regulation Name: Carbon Monoxide test system. Regulatory Class: Class I, reserved Product Code: MKU Dated: January 16, 2007 Received: January 18, 2007
Dear Dr. Kim:
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 fequire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please nother 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 tolling of (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K062565
Device Name: Status DS™ Nicotine
Indications For Use:
Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. Status DS ™ Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use
The Status DSTM Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Device
Evaluation and Safety
[K062565](https://510k.innolitics.com/search/K062565)
Page 1 of 1
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Indications for Use
510(k) Number (if known): K062565
Device Name: AccuSign® Nicotine
Indications For Use:
Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. AccuSign® Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use
The AccuSign® Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenee of DRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Device
idation and Safety
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§ 862.3220 Carbon monoxide test system.
(a)
Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.(b)
Classification. Class I (general 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.