(525 days)
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.
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.
The provided text describes a 510(k) premarket notification for an Acetaminophen assay (K202644). The document details various performance studies conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Precision (Within-Run %CV) | Not explicitly stated as acceptance criteria, but typically within acceptable laboratory limits for clinical assays. For example, for Control Level 1, %CV (0.9) is excellent; for Panel A, %CV (5.6) is higher but likely acceptable for low concentrations. | Control Level 1: Mean 15 µg/mL, SD 0.1, %CV 0.9Control Level 2: Mean 73 µg/mL, SD 0.5, %CV 0.6Control Level 3: Mean 227 µg/mL, SD 0.8, %CV 0.3Panel A: Mean 5 µg/mL, SD 0.3, %CV 5.6Panel B: Mean 51 µg/mL, SD 0.3, %CV 0.6Panel C: Mean 84 µg/mL, SD 0.4, %CV 0.4Panel D: Mean 278 µg/mL, SD 1.0, %CV 0.4Panel E: Mean 362 µg/mL, SD 1.6, %CV 0.4 |
| Precision (Within-Laboratory %CV) | Not explicitly stated as acceptance criteria, but typically within acceptable laboratory limits. | Control Level 1: SD 0.2, %CV 1.3Control Level 2: SD 0.6, %CV 0.8Control Level 3: SD 1.3, %CV 0.6Panel A: SD 0.5, %CV 9.1Panel B: SD 0.4, %CV 0.7Panel C: SD 0.6, %CV 0.7Panel D: SD 2.0, %CV 0.7Panel E: SD 2.6, %CV 0.7 |
| Reproducibility (%CV) | Not explicitly stated as acceptance criteria, but typically within acceptable laboratory limits. | Control 1: Mean 14 µg/mL, SD 0.5, %CV 3.2Control 2: Mean 68 µg/mL, SD 0.6, %CV 0.9Control 3: Mean 208 µg/mL, SD 1.6, %CV 0.8Panel: Mean 163 µg/mL, SD 1.2, %CV 0.7 |
| Limit of Blank (LoB) | Not explicitly stated, but should ideally be very low. | 0 µg/mL (0 µmol/L) |
| Limit of Detection (LoD) | The sponsor chose to use 1 µg/mL (7 µmol/L) for reporting purposes. | Scientific LoD: 0.2 µg/mL (1.3 µmol/L)Reporting LoD: 1 µg/mL (7 µmol/L) |
| Limit of Quantitation (LoQ) | The sponsor chose to use 3 µg/mL (20 µmol/L) for reporting purposes. This is the lower end of the analytical measuring interval. | Scientific LoQ: 1.9 µg/mL (12.6 µmol/L)Reporting LoQ (lower end of AMI): 3 µg/mL (20 µmol/L) |
| Linearity/Assay Range | Device demonstrated linearity across the range of 0 to 386 µg/mL, which spans the analytical measuring interval of 3 to 377 µg/mL. Implicit acceptance is that the assay is linear across its claimed analytical measuring interval. | Linear across 0 to 386 µg/mL. Analytical Measuring Interval: 3 to 377 µg/mL (20 to 2496 µmol/L). |
| Analytical Specificity (Interference) | Interference within ± 7.5% for acetaminophen samples > 20 µg/mL, ORwithin ± 1.50 µg/mL for acetaminophen samples < 20 µg/mL. | Specific endogenous and exogenous substances (e.g., conjugated bilirubin ≤ 14 mg/dL, hemoglobin ≤ 570 mg/dL, N-Acetylcysteine ≤ 1663 mg/L) tested and demonstrated to meet the acceptance criteria at the specified interferent levels. |
| Method Comparison (Correlation) | Not explicitly stated, but the predicate device has a strong correlation (0.9993) with the candidate. Implicit acceptance would be a high correlation coefficient (e.g., >0.975 or >0.98), slope close to 1, and intercept close to 0. | Correlation Coefficient: 0.9993Slope: 1.042Intercept: -0.034(Comparing 3.50 - 356.26 µg/mL (predicate) to 3.58 - 375.28 µg/mL (candidate)) |
| Matrix Comparison | Recovered within ± 7.5% for values ≥ 20 µg/mL, ORwithin ± 1.50 µg/mL for values < 20 µg/mL. | Serum, lithium heparin, lithium heparin mechanical separator, lithium heparin (separator tube), serum (separator tube), and sodium heparin tube types were found suitable for analysis. |
| Automated/Manual Dilution | Not explicitly stated, but results showed % difference of 1.5% to 5.3%, implying these met specific internal criteria for analytical accuracy of diluted samples. The range of 1.5% to 5.3% is generally considered excellent for dilution recovery. | Demonstrated % difference results of 1.5% to 5.3% when measuring samples above the analytical measuring interval by 1:10 autodilution vs. manual dilution methods. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision: 5 human serum panels and 3 control levels. Each assayed in a minimum of 2 replicates, twice per day on 20 days. N=120 for controls and panels.
- Reproducibility: 1 human serum panel and 3 control levels. Each assayed in a minimum of 3 replicates at 2 separate times per day on 5 different days. N=146-150 for controls and panel.
- Analytical Sensitivity (LoB, LoD, LoQ): Zero analyte samples and low analyte samples tested in replicates of 10.
- Linearity/Assay Reportable Range: One unique sample set, 13 sample levels, tested in a minimum of 2 replicates.
- Analytical Specificity (Interference): Test and reference samples tested in a minimum of 12 replicates.
- Method Comparison: 119 patient specimens (114 unaltered native samples, 5 contrived).
- Matrix Comparison: 78 matched specimen sets.
- Automated/Manual Dilution: 5 samples with high acetaminophen concentrations, tested in replicates of 42.
Data Provenance: The document does not explicitly state the country of origin of the data. The studies appear to be prospective as they were specifically designed and executed to evaluate the performance of the device for this submission (e.g., "A study was performed based on guidance...", "Testing was conducted according to CLSI EP05-A3...").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is typically associated with studies involving subjective interpretation, such as imaging or pathology studies. For an in vitro diagnostic (IVD) like this Acetaminophen assay, the "ground truth" is generally established using reference methods or gravimetric preparation of standards, rather than expert consensus on patient data.
- For Value Assignment: The Acetaminophen Calibrator is prepared gravimetrically from USP grade reference acetaminophen material to a specific concentration, and verified against a master calibrator (internal reference standard). This is the analytical "ground truth" for calibration.
- For Method Comparison: The predicate device is considered the "reference" for comparison, not a "ground truth" established by experts.
Therefore, the concept of "experts establishing ground truth" as you've defined it (e.g., radiologists) is not applicable to this type of IVD device performance study.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers or experts provide independent assessments, and discrepancies need to be resolved. Since this is an IVD device measuring an analyte quantitatively, and the "ground truth" is established analytically (gravimetric, reference methods, or predicate device results), an adjudication method in the traditional sense is not applicable. The studies involve quantitative measurements from instruments and comparisons to established analytical standards or methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic (IVD) device, specifically an assay for measuring acetaminophen levels, not an imaging or AI-assisted diagnostic tool that involves human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself (the Acetaminophen assay on the ARCHITECT c Systems) is a standalone system for quantitative measurement. The performance studies detailed (precision, linearity, method comparison, etc.) represent the standalone performance of the algorithm/reagent system as it processes samples on the automated platform without human intervention beyond sample loading and system operation. There is no "human-in-the-loop" component for interpretation of results in the direct sense; the device provides a quantitative number.
7. The Type of Ground Truth Used
The ground truth for the performance studies is established via:
- Gravimetric Preparation/Reference Standards: For analytical performance characteristics like calibrator value assignment, LoB, LoD, LoQ, and linearity. For example, calibrators are "prepared gravimetrically from USP grade reference acetaminophen material."
- Predicate Device Results: For the method comparison study, the results from the legally marketed predicate device (SEKURE Acetaminophen L3K Assay on Hitachi 717) serve as the comparative "reference" or "ground truth" against which the new device's performance is measured.
- Controlled Samples: For interference studies, samples with known concentrations of acetaminophen and specific interferents are used.
8. The Sample Size for the Training Set
The document does not mention a training set because this is not a machine learning or artificial intelligence (AI) device that requires extensive supervised learning. This is an enzymatic spectrophotometric assay, which relies on chemical reactions and optical measurement principles, not statistical pattern recognition trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of IVD device, this question is not applicable.
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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.
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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
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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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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, PECanada, C1E 2B9Establishment Registration Number: 8020316 |
|---|---|
| Application correspondent: | Penny WhiteSenior Manager, Regulatory Affairs902-628-0934Penny.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 | ProductCode |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen | Acetaminophen TestSystem | Class II21 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 themeasurement of acetaminophen concentration in human serum and plasma. Theassay consists two working reagents, an enzyme reagent and a color reagent. | |
| The enzyme reagent contains aryl acylamidase, which cleaves the amide bond ofacetaminophen, forming p-aminophenol which then reacts with the 2,5-dimethylphenol (contained the color reagent) in the presence of manganese. Theproduct of that reaction causes increased absorbance at 660 nm which is directlyproportional to the acetaminophen concentration in the sample. | |
| Testing is performed on the ARCHITECT c8000 clinical chemistry analyzers inconjunction 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 | |||
|---|---|---|---|---|---|
| CharacteristicSimilarities | SEKURE Acetaminophen L3K Assay | Acetaminophen | |||
| AnalyteMeasured | Acetaminophen | SAME | |||
| Intended Use | For the in vitro quantitativemeasurement of acetaminophen in serumand plasma.Measurement of acetaminophen is usedin the diagnosis and treatment ofacetaminophen overdose toxicity. | SAME | |||
| Methodology | Enzymatic (Aryl acylamidase) andSpectrophotometric (2,5-dimethylphenolchromophore) | SAME | |||
| Use of Calibrators | Yes | SAME | |||
| Use of Controls | Yes | SAME | |||
| General DeviceCharacteristicDifferences | SEKURE Acetaminophen L3K Assay | Acetaminophen | |||
| Specimen type | Serum and lithium heparin plasma | Serum, lithium heparin plasma andsodium heparin plasma | |||
| Platform | Hitachi 717 | ARCHITECT c8000 System | |||
| Measuringinterval | 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 | Meanµg/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 < 20 ug/mL at the levels listed in the tables below:
| Interferent | Interferent Level |
|---|---|
| Conjugated Bilirubin | ≤ 14 mg/dL |
| Unconjugated Bilirubin | ≤ 28 mg/dL |
| Hemoglobin | ≤ 570 mg/dL |
| Intralipid | ≤ 2000 mg/dL |
| Total Protein | ≤ 10 g/dL |
| Triglycerides | < 933 mg/dL |
Endogenous Substances:
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| Exogenous Substances: | |||
|---|---|---|---|
| T |
| Interferent | Interferent Level |
|---|---|
| Amitriptyline | ≤ 0.048 mg/dL |
| Ampicillin | ≤ 7.5 mg/dL |
| Benzocaine | ≤ 560 mg/L |
| Cefoxitin | ≤ 660 mg/dL |
| Codeine | ≤ 0.141 mg/dL |
| Cyclosporine | ≤ 0.18 mg/dL |
| Cysteamine | ≤ 220 µmol/L |
| Dapsone | ≤ 5.9 mg/L |
| Dipyrone/Metamizole | ≤ 100 mg/L |
| 2,5-Dihydroxybenzoic acid | ≤ 117 µmol/L |
| Doxycycline | ≤ 1.8 mg/dL |
| 4-Ethoxyaniline | <1.0 mmol/L |
| Ibuprofen | ≤ 21.9 mg/dL |
| Imipramine | ≤ 0.0315 mg/dL |
| L-Ascorbic Acid | ≤ 170 µmol/L |
| L-Cysteine | ≤ 18 mg/mL |
| Levodopa | ≤ 0.75 mg/dL |
| L-Methionine | ≤ 500 µg/mL |
| Methyldopa | ≤ 2.25 mg/dL |
| Metoclopramide | ≤ 1.5 µmol/L |
| Metronidazole | ≤ 12.3 mg/dL |
| N-Acetylcysteine | ≤ 1663 mg/L |
| N-Acetylprocainamide | ≤ 16 µg/mL |
| p-Aminosalicylic acid | ≤ 5.3 mmol/L |
| Phenacetin | ≤ 14 µg/mL |
| Phenylbutazone | ≤ 32.1 mg/dL |
| Procainamide | ≤ 102 µmol/L |
| Rifampicin | ≤ 80 µmol/L |
| Salicylic acid | <4.4 mmol/L |
| Tetracycline | ≤ 34 µmol/L |
| Theophylline | < 6.0 mg/dL |
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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.
Method Comparison Representative Results:
| Acetaminophen 3R74 on ARCHITECT c System vs Acetaminophen L3K 506 on Hitachi | |||||
|---|---|---|---|---|---|
| 506-30 onHitachi SampleRange (µg/mL) | 3R74 onARCHITECTSample Range(µg/mL) | N | Slope | Intercept | CorrelationCoefficient |
| 3.50 - 356.26 | 3.58 - 375.28 | 119 | 1.042 | -0.034 | 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.
The following tube types were compared to serum tubes (without gel in plastic) and recovered within the stated acceptance criteria of within ± 7.5% for values ≥ 20 µg/mL for values < 20 µg/mL for values < 20 µg/mL and are, therefore, suitable specimens for analysis:
Serum Lithium heparin Lithium heparin mechanical separator Lithium heparin (separator tube) Serum (separator tube) Sodium heparin
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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 µg/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.
Clinical studies
(clinical sensitivity, clinical specificity, other clinical supportive data)
Not Applicable
Expected values/Reference Range
The package insert contains the following reference ranges cited from literature. (Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 5th ed. St. Louis, MO:Elsevier; 2012:2176 and Rowden AK, Norvell J, Eldridge DL,et al. Acetaminophen poisoning. Clin Lab Med 2006;26(1):49-65.)
Therapeutic concentration: 10-30 µg/mL (66-199 µmol/L)
Toxic concentration:
4 hours > 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.
§ 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.