(133 days)
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No
The summary describes a chemical assay for measuring acetaminophen levels, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is an in vitro diagnostic device used to measure acetaminophen levels for diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is an in vitro diagnostic device" and that its measurements "are used in the diagnosis of acetaminophen toxicity and overdose."
No
The device description explicitly states it consists of "two reagents and a calibrator," which are physical components, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The statement explicitly says "The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma..." This directly identifies it as an in vitro diagnostic device.
- Purpose: The purpose is to measure a substance (acetaminophen) in a biological sample (serum or plasma) to aid in diagnosis (acetaminophen toxicity and overdose). This is a core function of IVDs.
- Components: The description mentions it consists of "two reagents and a calibrator," which are typical components of IVD assays used for chemical analysis of biological samples.
N/A
Intended Use / Indications for Use
The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.
Product codes
LDP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 862.3030 Acetaminophen test system.
(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 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 the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 7 2005
Ms. Marlene Walker Director of Quality Systems Diagnostic Chemicals Limited West Royalty Industrial Park 16 McCarville Street Charlottetown, PE Canada C1E 2A6
K042330 Re:
Trade/Device Name: Acetaminophen-Sl Assay, Cat. No. 505-10, 505-30 Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: December 17, 2004 Received: December 22, 2004
Dear Ms. Walker;
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.
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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ills letter will anow you to oegin marketing of substantial equivalence of your device to a legally prematics notification: "The PDT Intentig gour 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, 11 you desire specific morniation assusting of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the v in o Diagnostic Device Devilance and many and to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other 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/industry/support/index.html
Sincerely yours,
Camelia B. Rooks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K042330 510(k) Number (if known):
Device Name: Acetaminophen-SL Assay, Cat. No. 505-10, 505-30
Indications For Use:
The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
Carol C Ben
Division Sign-off
Offici of in the
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