(525 days)
No
The device description and performance studies focus on a standard enzymatic, spectrophotometric assay and its analytical performance characteristics. There is no mention of AI, ML, or any computational algorithms beyond standard data processing for calculating concentration from absorbance.
No
This device is an in vitro diagnostic (IVD) assay used to measure acetaminophen concentration in human serum or plasma. It aids in the diagnosis and treatment of acetaminophen overdose toxicity but does not directly provide therapy. Therefore, it is not a therapeutic device.
Yes
The intended use explicitly states the Acetaminophen assay is to be used "as an aid in the diagnosis and treatment of acetaminophen overdose toxicity."
No
The device description clearly states it is an enzymatic, spectrophotometric assay consisting of two working reagents (enzyme and color reagents) and is performed on a physical ARCHITECT c8000 clinical chemistry analyzer. This indicates it is a hardware-based assay with chemical components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the quantitative determination of acetaminophen in human serum or plasma. It also states it is used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity. This clearly indicates the device is intended for use on specimens derived from the human body for the purpose of providing information for diagnosis and treatment.
- Device Description: The description details an enzymatic, spectrophotometric assay that measures acetaminophen concentration in human serum and plasma. This describes a laboratory test performed on biological samples.
- Performance Studies: The document includes detailed performance studies (Precision, Reproducibility, Analytical Sensitivity, Linearity, Analytical Specificity, Method Comparison, Matrix Comparison, Automated and Manual Dilution) which are typical for the validation of an in vitro diagnostic device.
- Predicate Device: The mention of a "Predicate Device" (K081938; SEKURE Acetaminophen L3K Assay) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
- Intended User / Care Setting: The statement "For prescription use only" is also consistent with the regulatory requirements for many IVDs.
All of these elements align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease.
N/A
Intended Use / Indications for Use
The Acetaminophen assay is used for the quantitative determinophen in human serum or plasma on the ARCHITECT c Systems.
The Acetaminophen assay is to be used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.
Product codes
LDP
Device Description
The Acetaminophen assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in human serum and plasma. The assay consists two working reagents, an enzyme reagent and a color reagent.
The enzyme reagent contains aryl acylamidase, which cleaves the amide bond of acetaminophen, forming p-aminophenol which then reacts with the 2,5- dimethylphenol (contained the color reagent) in the presence of manganese. The product of that reaction causes increased absorbance at 660 nm which is directly proportional to the acetaminophen concentration in the sample.
Testing is performed on the ARCHITECT c8000 clinical chemistry analyzers in conjunction with a calibrator (510(k) exempt) which is provided separately.
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
For prescription use only.
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)
Precision
Testing was conducted according to CLSI EP05-A3 using 2 lots of the Acetaminophen reagent, two lots of the Acetaminophen Calibrator, 1 lot of commercially available controls and 1 ARCHITECT c8000 instrument. Three levels of controls and 5 human serum panels were assayed in a minimum of 2 replicates, twice per day on 20 days on 2 reagent lot/calibrator lot combinations, where a unique reagent lot and unique calibrator lot is paired.
Reproducibility
Testing was conducted according to CLSI EP05-A3 using 1 lot of Acetaminophen reagent, a minimum of 1 lot of Acetaminophen Calibrator, 1 lot of commercially available controls, and 3 ARCHITECT instruments. Three levels of controls and 1 human serum panel were assayed in a minimum of 3 replicates at 2 separate times per day on 5 different days.
Analytical Sensitivity
A study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2. The zero analyte samples were tested in replicates of 10. The low analyte samples were tested in replicates of 10. Testing was conducted using 2 lots of the Acetaminophen reagent on 1 instrument over a minimum of 3 days. The LoB was 0 ug/mL (0 umol/L), the LoD was 0.2 ug/mL (1.3 umol/L), and the LoQ was 1.9 ug/mL (12.6 umol/L). For results reporting purposes, the sponsor chose to use 1 ug/mL (7 umol/L) for the LoD and 3 ug/mL (20 umol/L) for the LoQ.
Linearity/Assay Reportable Range
Linearity was evaluated based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP06-A. One unique sample set was prepared by combining a low and high acetaminophen sample (human serum). The 13 sample levels were tested using the Acetaminophen assay in a minimum of 2 replicates using two lots of the Acetaminophen Calibrator, 1 lot of commercially available controls and 1 instrument. The Acetaminophen assay was demonstrated to be linear across the range of 0 to 386 ug/mL, which spans the analytical measuring interval of 3 to 377 ug/mL.
Analytical Specificity (Endogenous and Exogenous Interference)
Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2. Interference effects were assessed by comparing test samples containing potentially interfering endogenous and exogeneous substances to reference samples. Each test and reference sample were tested in a minimum of 12 replicates using 1 lot of reagent, 1 lot of calibrator and 1 lot of commercially available controls on 1 ARCHITECT c8000 System.
Method Comparison with Predicate Device
Method comparison testing was conducted based on CLSI EP09-A3 on 1 ARCHITECT c8000 analyzer using two lots of the Acetaminophen assay and two lots of Acetaminophen Calibrator and two lots of the predicate device Acetaminophen L3K reagent on 1 Hitachi 717 analyzer. Testing was completed on 119 patient specimens in duplicate over five operating days. Of the 119 samples, 114 were unaltered native samples and 5 (4% of the total) were contrived. The correlation coefficient was 0.9993.
Matrix Comparison
A matrix comparison study was performed to assess the Acetaminophen assay using serum and plasma. The study was performed using one lot of reagent and one lot of calibrator on one ARCHITECT c8000 instrument. The acetaminophen concentrations spanned the assay range. A set of seventy-eight matched specimen sets were collected and tested.
Automated and Manual Dilution
A study was performed to assess the ability of the Acetaminophen assay to accurately measure samples having concentrations above the analytical measuring interval after they have been automatically diluted or manually diluted. This study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP34, 1st ed. Five samples with Acetaminophen concentrations within the range of 450 ug/mL to 3,000 ug/mL tested. All dilutions were performed at a 1:10 dilutions were performed using 0.9% (NaCl). The samples were tested in replicates of 42 for precision and dilution recovery testing using 1 lot of reagent, 1 lot of reagent, 1 lot of calibrator and 1 lot of commercially available controls on 1 ARCHITECT c8000 System. The Acetaminophen assay demonstrated % difference results of 1.5% to 5.3% when measuring samples having concentrations above the analytical measuring interval by 1:10 autodilution vs manual dilution method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 18, 2022
Sekisui Diagnostics P.E.I. INC. Pennv White Senior Manager, Regulatory Affairs 70 Watts Avenue Charlottetown, PE C1E 2B9 Canada
Re: K202644
Trade/Device Name: Acetaminophen Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen Test System Regulatory Class: Class II Product Code: LDP Dated: November 19, 2021 Received: November 22, 2021
Dear Penny 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202644
Device Name Acetaminophen
Indications for Use (Describe)
The Acetaminophen assay is used for the quantitative determinophen in human serum or plasma on the ARCHITECT c Systems.
The Acetaminophen assay is to be used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR §807.92. This is a Traditional 510(k).
The assigned 510(k) number: K202644
Applicant Information and Date [807.92(a)(1)] 1.
| Applicant Name and Address: | SEKISUI DIAGNOSTICS P.E.I. INC.
70 Watts Avenue, Charlottetown, PE
Canada, C1E 2B9
Establishment Registration Number: 8020316 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Application correspondent: | Penny White
Senior Manager, Regulatory Affairs
902-628-0934
Penny.white@sekisuidiagnostics.com |
Date Summary prepared:
February 8, 2022
2_ Device Name and Classification [807.92(a)(2)]
| Proprietary Name | Common Name | Classification Name | Classification | Product
Code |
|------------------|---------------|------------------------------|-----------------------------|-----------------|
| Acetaminophen | Acetaminophen | Acetaminophen Test
System | Class II
21 CFR 862.3030 | LDP |
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3. ___________________________________________________________________________________________________________________________________________________________________________ Identification of Legally Marketed Predicate Devices [807.92(a)(3)]
| Predicate Device | Predicate 510(k) Number |
|---|---|
| SEKURE Acetaminophen L3K Assay | K081938 |
4. Device Description [807.92(a)(4)]
| Trade Name | Device Description |
|---|---|
| Acetaminophen | List 03R7420 Tests per kit 200 |
| The Acetaminophen assay is an enzymatic, spectrophotometric assay for the | |
| measurement of acetaminophen concentration in human serum and plasma. The | |
| assay consists two working reagents, an enzyme reagent and a color reagent. | |
| The enzyme reagent contains aryl acylamidase, which cleaves the amide bond of | |
| acetaminophen, forming p-aminophenol which then reacts with the 2,5- | |
| dimethylphenol (contained the color reagent) in the presence of manganese. The | |
| product of that reaction causes increased absorbance at 660 nm which is directly | |
| proportional to the acetaminophen concentration in the sample. | |
| Testing is performed on the ARCHITECT c8000 clinical chemistry analyzers in | |
| conjunction with a calibrator (510(k) exempt) which is provided separately. |
| Assay Component | Reactive Ingredient | Concentration |
|---|---|---|
| Reagent 1 (2 x 8.6 mL) | Manganese (II) Chloride | 0.3 mmol/L |
| Aryl acylamidase | 0.9 KU/L | |
| Reagent 2 (2 x 22.3 mL) | 2,5-dimethylphenol | 31 mmol/L |
5. Intended Use [807.92(a)(5)]
The Acetaminophen assay is intended for the in vitro quantitative determination of acetaminophen in human serum or plasma on the ARCHITECT c System. The acetaminophen assay is to be used as an aid in the diagnosis and treatment of patients suspected of acetaminophen overdose toxicity.
For prescription use only.
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Technological Similarities and Differences to the Predicate [807.92(a)(6)] 6. ___________________________________________________________________________________________________________________________________________________________________________
The Acetaminophen assay is used for the quantitative determination of acetaminophen in human serum and plasma on the ACHITECT c Systems.
A comparison of the candidate assay (Acetaminophen, List number 03R7420) and the predicate assay (Acetaminophen L3K Assay Part number 506-30) is presented in the table below:
| General Device | Predicate Device (K081938) | Candidate Device | |||
|---|---|---|---|---|---|
| Characteristic | |||||
| Similarities | SEKURE Acetaminophen L3K Assay | Acetaminophen | |||
| Analyte | |||||
| Measured | Acetaminophen | SAME | |||
| Intended Use | For the in vitro quantitative | ||||
| measurement of acetaminophen in serum | |||||
| and plasma. | |||||
| Measurement of acetaminophen is used | |||||
| in the diagnosis and treatment of | |||||
| acetaminophen overdose toxicity. | SAME | ||||
| Methodology | Enzymatic (Aryl acylamidase) and | ||||
| Spectrophotometric (2,5-dimethylphenol | |||||
| chromophore) | SAME | ||||
| Use of Calibrators | Yes | SAME | |||
| Use of Controls | Yes | SAME | |||
| General Device | |||||
| Characteristic | |||||
| Differences | SEKURE Acetaminophen L3K Assay | Acetaminophen | |||
| Specimen type | Serum and lithium heparin plasma | Serum, lithium heparin plasma and | |||
| sodium heparin plasma | |||||
| Platform | Hitachi 717 | ARCHITECT c8000 System | |||
| Measuring | |||||
| interval | 0.6 to 377.5 ug/mL (4 to 2500 umol/L) | 3 to 377 ug/mL (20 to 2496 umol/L) |
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7. Summary of Non-Clinical Performance Data [807.92 (b)(1), 807.92 (b)(3)]
Precision
Testing was conducted according to CLSI EP05-A3 using 2 lots of the Acetaminophen reagent, two lots of the Acetaminophen Calibrator, 1 lot of commercially available controls and 1 ARCHITECT c8000 instrument. Three levels of controls and 5 human serum panels were assayed in a minimum of 2 replicates, twice per day on 20 days on 2 reagent lot/calibrator lot combinations, where a unique reagent lot and unique calibrator lot is paired. The performance from a representative commarized in the following table.
ªIncludes within run, between run, and between-day variability.
| Within-Run | Within-Laboratorya | ||||||
|---|---|---|---|---|---|---|---|
| Sample | N | Mean | |||||
| (µg/mL) | SD | %CV | SD | SD 95% CI | %CV | ||
| Control Level 1 | 120 | 15 | 0.1 | 0.9 | 0.2 | (0.2, 0.2) | 1.3 |
| Control Level 2 | 119 | 73 | 0.5 | 0.6 | 0.6 | (0.5, 0.7) | 0.8 |
| Control Level 3 | 120 | 227 | 0.8 | 0.3 | 1.3 | (1.1, 1.6) | 0.6 |
| Panel A | 120 | 5 | 0.3 | 5.6 | 0.5 | (0.4, 0.6) | 9.1 |
| Panel B | 120 | 51 | 0.3 | 0.6 | 0.4 | (0.3, 0.5) | 0.7 |
| Panel C | 120 | 84 | 0.4 | 0.4 | 0.6 | (0.5, 0.7) | 0.7 |
| Panel D | 120 | 278 | 1.0 | 0.4 | 2.0 | (1.6, 2.5) | 0.7 |
| Panel E | 120 | 362 | 1.6 | 0.4 | 2.6 | (2.2, 3.2) | 0.7 |
Reproducibility
Testing was conducted according to CLSI EP05-A3 using 1 lot of Acetaminophen reagent, a minimum of 1 lot of Acetaminophen Calibrator, 1 lot of commercially available controls, and 3 ARCHITECT instruments. Three levels of controls and 1 human serum panel were assayed in a minimum of 3 replicates at 2 separate times per day on 5 different days.
| Sample | N | Mean
µg/mL | Repeatability | | Within-
Laboratorya | | Reproducibilityb | |
|-----------|-----|---------------|---------------|-----|------------------------|-----|------------------|-----|
| | | | SD | %CV | SD | %CV | SD | %CV |
| Control 1 | 146 | 14 | 0.3 | 1.8 | 0.4 | 3.1 | 0.5 | 3.2 |
| Control 2 | 149 | 68 | 0.3 | 0.5 | 0.5 | 0.8 | 0.6 | 0.9 |
| Control 3 | 150 | 208 | 0.8 | 0.4 | 1.3 | 0.6 | 1.6 | 0.8 |
| Panel | 147 | 163 | 0.6 | 0.4 | 1.0 | 0.6 | 1.2 | 0.7 |
a Within-Laboratory variability contains repeatability (within-run), between-day variability.
b Reproducibility contains repeatability (within-run), between-day, and between-instrument variability.
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Analytical Sensitivity
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation
A study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2.
The zero analyte samples were tested in replicates of 10. The low analyte samples were tested in replicates of 10. Testing was conducted using 2 lots of the Acetaminophen reagent on 1 instrument over a minimum of 3 days.
The LoB was 0 µg/mL (0 µmol/L), the LoD was 0.2 µg/mL (1.3 µmol/L), and the LoQ was 1.9 µg/mL (12.6 umol/L). For results reporting purposes, the sponsor chose to use 1 ug/mL (7 umol/L) for the LoD and 3 ug/mL (20 umol/L) for the LoQ.
Linearity/Assay Reportable Range
Linearity was evaluated based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP06-A.
One unique sample set was prepared by combining a low and high acetaminophen sample (human serum). The 13 sample levels were tested using the Acetaminophen assay in a minimum of 2 replicates using two lots of the Acetaminophen Calibrator, 1 lot of commercially available controls and 1 instrument.
The Acetaminophen assay was demonstrated to be linear across the range of 0 to 386 µg/mL, which spans the analytical measuring interval of 3 to 377 ug/mL.
Traceability, Stability (controls, calibrators or methods)
Value Assignment
The Acetaminophen Calibrator is prepared gravimetrically from USP grade reference acetaminophen material to a concentration of 151 ug/mL (1000 umol/L). The calibrator preparation is verified against the master calibrator (an internal reference standard). Two lots of Acetaminophen Calibrator were verified and met acceptance criteria.
Analytical Specificity (Endogenous and Exogenous Interference)
Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2.
Interference effects were assessed by comparing test samples containing potentially interfering endogenous and exogeneous substances to reference samples.
Each test and reference sample were tested in a minimum of 12 replicates using 1 lot of reagent, 1 lot of calibrator and 1 lot of commercially available controls on 1 ARCHITECT c8000 System.
The following potentially interfering substances demonstrated interference within ± 7.5% for acetaminophen samples > 20 ug/mL or within ± 1.50 ug/mL for acetaminophen samples 150 µg/mL (> 993 µmol/L)
24 hours > 4.7 ug/mL (> 31 umol/L)
These values are suggested guidelines. It is recommended that each laboratory establish its own expected range.
8. Conclusion
The results presented in these 510(k) premarket notifications demonstrate that the candidate assay (Acetaminophen, List No. 03R74) performance is substantially equivalent to the predicate assay (SEKURE Acetaminophen L3K, List No. 506-30).
The similarities and differences between the candidate assay and the predicate assay are presented in the table 5.6. The results presented in this 510(k) provide reasonable assurance that the Acetaminophen assay is safe and effective for the stated intended use. Any differences between the candidate assay and the predicate assay shown in the tables do not affect the safety and effectiveness of the candidate assay.
There is no known potential adverse effect to the operator when using this device according to the Acetaminophen package insert instructions.