(35 days)
Not Found
Not Found
No
The description details a standard enzymatic and colorimetric assay for measuring acetaminophen, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as an "in vitro diagnostic test" intended to measure drug levels for diagnosis and treatment, not to directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test" and that its measurements "are used in the diagnosis and treatment of acetaminophen overdose."
No
The device is a reagent cartridge used on a clinical chemistry system, which are physical components and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ACTM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure the drug acetaminophen in plasma and serum."
This statement directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
"The ACTM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure the drug acetaminophen in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose."
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
"The ACTM method is based on the enzymatic hydrolysis of acetaminophen producing acetate and p-aminophenol. The amount of p-aminophenol is measured colorimetrically and is proportional to the acetaminophen concentration."
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
One hundred fifty-four serum or plasma samples were tested with the ACTM FLEX™ reagent cartridge on the Dimension® system and the aca® ACTMN analytical test pack on the aca® discrete clinical analyzer
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"slope = 1.04 intercept = - 3.27 correlation coefficient = 0.998 range of samples = 10.2 - 295.0 µg/mL"
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.
aca® acetaminophen test pack
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
§ 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
DADE INTERNATIONAL
emistry Systems 0. Box 6101 Newark, DE 19714
SEP 23 1996
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Acetaminophen FLEX™ Reagent Cartridge
Summary of Safety and Effectiveness
The ACTM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure the drug acetaminophen in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
The ACTM method is based on the enzymatic hydrolysis of acetaminophen producing acetate and p-aminophenol. The amount of p-aminophenol is measured colorimetrically and is proportional to the acetaminophen concentration.
The ACTM FLEX™ reagent cartridge is substantially equivalent to the aca® acetaminophen test pack, which was cleared by the FDA via the 510(k) process. Both tests use prepackaged reagents for the determination of acetaminophen in human serum and plasma.
One hundred fifty-four serum or plasma samples were tested with the ACTM FLEX™ reagent cartridge on the Dimension® system and the aca® ACTMN analytical test pack on the aca® discrete clinical analyzer, with the following results:
slope = 1.04 intercept = - 3.27 correlation coefficient = 0.998 range of samples = 10.2 - 295.0 µg/mL
Carolyn K. George
Carolyn K. George
Carolyn K. Georg Regulatory Affairs and Compliance Manager
September 4, 1996
Date
Printed on recycled paper
with 25% post-consumer fiber