(50 days)
Not Found
Not Found
No
The summary describes a device for quantitative determination of acetaminophen in human serum, which is a chemical analysis. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
This device is for the determination of acetaminophen in human serum for in vitro diagnostic use, not for direct therapeutic treatment or intervention. While it aids in managing overdose, it is not a therapeutic device itself.
Yes
The document explicitly states "For quantitative, in vitro, diagnostic use." This indicates the device is used for diagnosis.
No
The intended use describes a device for the determination of acetaminophen in human serum, which is an in vitro diagnostic (IVD) use. IVD devices typically involve hardware components for sample analysis, and the provided information does not indicate this is a software-only interpretation of data from a separate IVD device. The lack of a device description further supports this conclusion.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the determination of acetaminophen in human serum." This indicates the device is used to analyze a biological sample (human serum) outside of the body.
- Indications for Use: The indications for use describe the clinical context for using the device, which is related to diagnosing and managing acetaminophen overdose. This is a diagnostic purpose.
- Quantitative, in vitro, diagnostic use: The final sentence of the Intended Use section explicitly states "For quantitative, in vitro, diagnostic use." This directly confirms its classification as an in vitro diagnostic device.
The analysis of human serum to determine the concentration of a substance like acetaminophen for diagnostic purposes is a core function of an IVD.
N/A
Intended Use / Indications for Use
For the determination of acetaminophen in human serum. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated (4,5,6).
The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 1324 umol/L (20 mg/dL). Nacetylcysteine has been used as an antidote in conjunction with intensive support care. Early diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within 8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7).
For quantitative, in vitro, diagnostic use.
Product codes
LDP
Device Description
Not Found
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
Not Found
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)
Not Found
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.
Not Found
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
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping bodies, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY | 2 1998
Karen Callbeck, R.T.B.Sc. . Diagnostic Chemicals Limited 16 First Street West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0
Re : K981059 Acetaminophen-SL Assay Requlatory Class: II Product Code: LDP Dated: March 19, 1998 Received: March 23, 1998
Dear Ms. Callbeck:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Adminestration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
2
| -11/1
00W11 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- SE IN MILL LEBELLER FREE EN FREED FOR FOR
CAR AND THE COLOR COLLECTION COLORIES OF CLASS OF COLLECTION OF CLASS OF |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Device Name: Acetaminophen-SL Assay
Indications for Use:
For the determination of acetaminophen in human serum. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated (4,5,6).
The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 1324 umol/L (20 mg/dL). Nacetylcysteine has been used as an antidote in conjunction with intensive support care. Early diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within 8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7).
For quantitative, in vitro, diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Veronica I. Cairun for a Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981059
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)