(297 days)
Not Found
No
The summary describes a quantitative chemical assay for acetaminophen, with no mention of AI/ML, image processing, or data-driven algorithms for analysis.
No
The device measures acetaminophen levels for diagnosis and treatment of overdose, but it does not directly treat the patient.
Yes
The device is described as being used for the "diagnosis and treatment of acetaminophen overdose toxicity," which directly indicates a diagnostic purpose.
No
The device description explicitly states it is a "Reagent is a two-part liquid in plastic bottles packaged in the appropriate box," indicating it is a chemical reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use explicitly states "For the quantitative measurement of acetaminophen in serum and plasma." This indicates the device is used to analyze biological samples (serum and plasma) in vitro (outside the body).
- Purpose: The purpose of the measurement is "used in the diagnosis and treatment of acetaminophen overdose toxicity." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description mentions analyzing "serum and plasma" and that the "Reagent is a two-part liquid in plastic bottles." This further confirms it's a laboratory-based test using reagents to analyze biological samples.
The information provided clearly indicates that this device is designed to perform a test on biological samples in vitro to aid in diagnosis and treatment, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of scycre liver damage caused by overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. For IN VITRO diagnostic use.
Product codes
LDP
Device Description
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated.
Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
Acetaminophen Enzyme Reagent (R1): buffer (pH 8.6 at 25 ℃ ) 0.2 mmol/L MnCl2 . 4H2O, ≥ 0.9 KU/L Acyl Amidohydrolase, surfactant, preservatives.
Acetaminophen Color Reagent (R2): 0.1 mol/L sodium carbonate buffer (pH 12.2 at 25 ℃ ), 30 mmol/L 8-hydroxyquinolinc-5-sulfonic acid, surfactant, preservatives.
Acetaminophen Standard: buffer (pH 5.0 at 25 ℃ ), 1000μmol/L (15.1 mg/dL) acetaminophen, preservatives.
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
Method comparison study:
Serum: Deming regression using NCCLS EP9-A2. Comparison between this method and a similar acetaminophen method using 100 samples in serum ranging from 26 to 2361 @mol/L. Correlation coefficient was 0.9999. Deming regression analysis gave the following equation: This method = 1.060(reference method) + 4.6 @mol/L. Confidence interval is 95%. The amount of scatter around the estimate regression line is 8.9.
Plasma: Comparison made between serum and plasma using 25 samples ranging from 30 to 2441 umol/L. Correlation coefficient was 0.9999. Linear regression analysis gave the following equation: This method (plasma) = 0.999 [This method (serum)] -2.2 umol/L.
Key Metrics
Serum: Correlation coefficient = 0.9999.
Plasma: Correlation coefficient = 0.9999.
Predicate Device(s)
Reference Device(s)
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
MAY
- 1 2009
Acetaminophen L3K® Assay
Product Cat. No. 506-10 & 506-30
510(K) SUMMARY
Introduction: 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.
Genzyme Diagnostics P.E.I. Inc. Submitter: 70 Watts Avenue Charlottetown, P.E.I. Canada C1E 2B9 (Tel:) (902)566-1396 (Fax:) (902)628-6504
Contact Person: Penny White
Date Prepared: June 1, 2008
Acetaminophen L3K® Assay Device Name: Tradename: FDA Regulation Name: 862.3030 Colorimetry, Acetaminophen FDA Product Code: LDP
Predicate Device: Genzyme Diagnostics P.E.I. Inc. (K042330)
Device Description: For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated.
Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
Intended Use For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acctaminophen is used in the diagnosis and treatment of scycre liver damage caused by overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. For IN VITRO diagnostic use.
1
Comparison to Predicate Device:
Description of the Item Being Compared:
For the In Vitro quantitative measurement
Acetaminophen Enzyme Reagent (R1): buffer (pH 8.6 at 25 ℃ ) 0.2 mmol/L MnCl2 . 4H2O, ≥ 0.9 KU/L Acyl Amidohydrolase, surfactant, preservatives.
Acetaminophen Color Reagent (R2): 0.1 mol/L sodium carbonate buffer (pH 12.2 at 25 ℃ ), 30 mmol/L 8-hydroxyquinolinc-5-sulfonic acid, surfactant, preservatives.
Acetaminophen Standard: buffer (pH 5.0 at 25 ℃ ), 1000μmol/L (15.1 mg/dL) acetaminophen, preservatives.
Similaries:
The submission device and the predicate device have the same intended use.
The submission device and the predicate device both use Aryl Acylamidase enzyme method in acetaminophen measurement.
The submission device and the predicate device have the same oxidative coupling method.
Differences:
The predicate device uses a different chromophore in the oxidative coupling reaction during color development.
The predicate devices uses 8 hydroxyquinoline and the submission device uses 2,5 dimethylphenol.
Comments on Substantial Equivalence:
Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device. Method comparison results provided the following:
Serum
Deming regression using NCCLS EP9-A2.
A comparison was made between this method and a similar acetaminophen method using 100 samples in serum ranging from 26 to 2361 @mol/L. The correlation coefficient was 0.9999. Deming regression analysis gave the following equation:
This method = 1.060(reference method) + 4.6 @mol/L
2
Confidence interval is 95%. Correlation coefficient is 0.9999. The amount of scatter around the estimate regression line is 8.9. The approach is not different from the predicate device.
Plasma
A comparison was made between serum and plasma using 25 samples ranging from 30 to 2441 umol/L. The correlation coefficient was 0.9999. Linear regression analysis gave the following equation:
This method (plasma) = 0.999 [This method (serum)] -2.2 umol/L
Genzyme Diagnostics P.E.I. Inc. Acetaminophen L3K® Assay is Conclusion: substantially cquivalent in principle and performance to the predicate product.
Penny White Regulatory Affairs Coordinator Genzyme Diagnostics P.E.I. Inc.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
MAY - 1 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Genzyme Diagnostics P.E.I. Inc. c/o Ms. Penny J. White Regulatory Affairs Coordinate 70 Watts Avenue Charlottetown, Prince Edward Island Canada C1E 2B9
Re: K081938
Trade/Device Name: Acetaminophen L3K Assay Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: April 8, 2009 Received: April 27, 2009
Dear Ms. White:
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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 cquivalence 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
A.C.H
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K081938
Device Name: Acetaminophen L3K Assay
Indication For Use:
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Lucy Phillips
Office of In Vitro Diagnostic Device Evaluation and Safety
4081938 510(k)