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510(k) Data Aggregation
(525 days)
Sekisui Diagnostics P.E.I. INC.
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 0.9 |
| Control Level 2: Mean 73 µg/mL, SD 0.5, %CV 0.6 | ||
| Control Level 3: Mean 227 µg/mL, SD 0.8, %CV 0.3 | ||
| Panel A: Mean 5 µg/mL, SD 0.3, %CV 5.6 | ||
| Panel B: Mean 51 µg/mL, SD 0.3, %CV 0.6 | ||
| Panel C: Mean 84 µg/mL, SD 0.4, %CV 0.4 | ||
| Panel D: Mean 278 µg/mL, SD 1.0, %CV 0.4 | ||
| Panel 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 1.3 |
| Control Level 2: SD 0.6, %CV 0.8 | ||
| Control Level 3: SD 1.3, %CV 0.6 | ||
| Panel A: SD 0.5, %CV 9.1 | ||
| Panel B: SD 0.4, %CV 0.7 | ||
| Panel C: SD 0.6, %CV 0.7 | ||
| Panel D: SD 2.0, %CV 0.7 | ||
| Panel 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 3.2 |
| Control 2: Mean 68 µg/mL, SD 0.6, %CV 0.9 | ||
| Control 3: Mean 208 µg/mL, SD 1.6, %CV 0.8 | ||
| Panel: 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, OR | |
| within ± 1.50 µg/mL for acetaminophen samples 0.975 or >0.98), slope close to 1, and intercept close to 0. | Correlation Coefficient: 0.9993 | |
| Slope: 1.042 | ||
| Intercept: -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, OR | |
| within ± 1.50 µg/mL for values |
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(202 days)
SEKISUI DIAGNOSTICS P.E.I. INC.
For the in vitro quantitative measurement of creatine kinase activity in serum and plasma on the SK500 Clinical Chemistry System. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
The SEKURE Creatine Kinase Assay (CK Assay) is a spectrophotometric, coupled enzyme assay for the quantitative measurement of creatine kinase (CK) activity. The assay consists of two working reagents, a buffer solution (R1) and a substrate reagent (R2). The SEKURE CK Assay employs the reverse reaction of CK, to produce adenosine triphosphate (ATP). The reaction is coupled to hexokinase and G6PDH which consumes ATP to generate NADPH. The rate of NADPH formation is monitored at 340 nm and is directly proportional to CK activity. Testing is performed on the SK500 in conjunction with calibrator and controls which are provided separately.
The SK500 Analyzer is manufactured as Clinical Chemistry Analyzer Tokyo Boeki Medisys Inc. Biolis 50i Superior. "SK500" is the Sekisui Diagnostics labelled name for the Tokyo Boeki Medisys Inc. Biolis 50i Superior instrument.
This document describes the SEKURE Creatine Kinase Assay, an in vitro diagnostic device, and its performance study to demonstrate substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The device performance is evaluated against various analytical metrics. While explicit "acceptance criteria" for each study are not individually listed as pass/fail thresholds in a table, the document reports the results of these studies, implying that the observed performance met internal or regulatory expectations for demonstrating substantial equivalence. The predicate device's characteristics serve as an implicit benchmark for similarity.
Here's a table summarizing the reported device performance, with implied acceptance based on the submission being cleared:
| Feature/Study | Acceptance Criteria (Implied) | Reported Device Performance (SEKURE Creatine Kinase Assay) | Predicate Device Performance (Creatine Kinase-SL Assay) |
|---|---|---|---|
| Intended Use | Quantitative measurement of CK activity in serum. | Quantitative measurement of CK activity in serum and plasma on SK500. | Quantitative measurement of CK activity in serum. |
| Methodology | Must be similar to predicate. | Colorimetric (NADPH), Enzymatic (coupled hexokinase-G6PD) | Colorimetric (NADPH), Enzymatic (coupled hexokinase-G6PD) |
| Specimen Type | Suitable for reported specimen types. | Serum and lithium heparin plasma. | Serum |
| Measuring Interval | Within a clinically relevant and acceptable range, similar to predicate. | 11-1500 U/L | 2-1500 U/L |
| Precision | Acceptable repeatability and within-laboratory variability (%CV, SD). CLSI EP05-A3 guidelines. | See Section "Precision" table (e.g., Repeatability %CV ranging from 0.6-1.3%, Within Laboratory %CV ranging from 1.2-3.6%). | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Blank (LoB) | Must be low and clinically acceptable. CLSI EP17-A2 guidance. | 3 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Detection (LoD) | Must be low and clinically acceptable. CLSI EP17-A2 guidance. | 5 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Quantitation (LoQ) | Clinically acceptable level. CLSI EP17-A2 guidance. | 11 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Linearity/Reportable Range | Observed mean values within ±10% or ±3 U/L of theoretical values. CLSI EP06-A guidance. | Supported measuring range up to 1500 U/L for serum and plasma. | 2-1500 U/L |
| Analytical Specificity (Interference) | Significant interference |
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(35 days)
SEKISUI DIAGNOSTICS P.E.I. INC.
For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.
DC-UIBC-CAL is a human based, lyophilized serum intended for use as a calibrator with Sekisui Diagnostics UIBC Assays. The concentrations and activities of the UIBC (Unsaturated Iron Binding Capacity) is optimized for the calibration of clinical chemistry systems - Beckman Coulter AU® Systems, Roche/Hitachi® Beckman Coulter SYNCHRON® Systems, and Cobas Mira®.
The DC-UIBC-CAL kit consists of the following:
Six vials with 10mL of lyophilized serum.
Human serum was used in the manufacture of this product. The human serum in this product has been prepared exclusively from the blood of donors tested individually and shown by FDAapproved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no test method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient sample. In the event of exposure, the directives of the responsible Health Authorities should be followed.
The provided text describes a 510(k) submission for a medical device called DC-UIBC-CAL, a calibrator for clinical chemistry assays. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a full de novo performance study. As such, many of the typical elements requested for software-based AI/ML device studies are not present.
Here's an analysis based on the provided text, indicating where information is present and where it is not applicable or not provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device.
The reported performance is primarily around stability and traceability/value assignment.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate | The information presented in the premarket notification demonstrates that the performance of the Sekisui Diagnostics modified DC-UIBC-CAL is substantially equivalent to the cleared predicate device. |
| Shelf Life Stability | Accelerated stability studies for shelf life were conducted, and acceptance criteria were met. The DC-UIBC-CAL is stable at 2-8 °C for 36 months or until the expiration date. Real-time studies are ongoing. |
| Open Vial Stability (Reconstituted) | Acceptance criteria were met. Reconstituted product is stable at 2-8 °C for 14 days. |
| Traceability of UIBC Values | UIBC values are traceable to NIST SRM 937. Sekisui verifies UIBC is within acceptable target range using Sekisui protocol. |
| Target Range Consistency Across Instruments | For UIBC-SL Reagent 153-10/30/50/90, the target range across Beckman Coulter AU, Beckman Coulter SYNCHRON, Roche/Hitachi, and Cobas Mira systems is 208 – 312 µg/dL. Specific target values are provided (e.g., 238 µg/dL for Beckman Coulter AU Systems). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document relates to a calibrator, not a diagnostic test for patient samples. Therefore, the concept of a "test set" for patient data, sample size, and data provenance (country, retrospective/prospective) as typically applied to diagnostic algorithms is not applicable here.
The stability studies would have involved multiple units of the calibrator product. The traceability and value assignment involved using two reagent lots on instruments. No specific sample sizes for these internal validation tests are provided.
The device itself is manufactured using human serum, and mentions that "Human serum was used in the manufacture of this product."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable. The device is a calibrator, not an interpretative AI/ML diagnostic device. Ground truth for a calibrator relates to its chemical composition and assigned values, which are established through metrological traceability to reference materials (like NIST SRM 937) and internal protocols, not through expert human review of diagnostic outputs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for a calibrator device.
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
Not applicable. This is not an AI/ML diagnostic device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a calibrator, a physical reagent device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the calibrator's UIBC concentration is established through metrological traceability to a reference material, specifically NIST SRM 937 (National Institute of Standards and Technology Standard Reference Material 937). Internal Sekisui protocols are also used for value assignment. This is a chemical/physical ground truth, not a clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
Not applicable. This is a calibrator, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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(149 days)
SEKISUI DIAGNOSTICS P.E.I. INC.
The Sekisui Magnesium Assay is for the quantitative determination of magnesium in human serum and plasma (Lithium Heparin) on automated chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.
The Sekisui Magnesium assay kit consists of the following: Magnesium Reagent: A solution containing buffer (pH 11.2 at 25°C), 0.14 mmol/L xylidy/ blue-1, 0.1 mmol/L EGTÅ, and a surfactant.
Here's a breakdown of the acceptance criteria and the study information for the Sekisui Magnesium Assay, based on the provided text:
Acceptance Criteria and Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance (Sekisui Magnesium Assay) |
|---|---|---|
| Precision | Total CV%: | |
| 0.8 mg/dL (low) | N/A (evaluated per CLSI EP5-A2) | 6.1% |
| 2.0 mg/dL (mid) | N/A (evaluated per CLSI EP5-A2) | 3.7% |
| 4.7 mg/dL (high) | N/A (evaluated per CLSI EP5-A2) | 3.2% |
| Within Run CV%: | ||
| 0.9 mg/dL (low) | N/A (evaluated per CLSI EP5-A2) | 7.0% |
| 2.0 mg/dL (mid) | N/A (evaluated per CLSI EP5-A2) | 2.2% |
| 4.9 mg/dL (high) | N/A (evaluated per CLSI EP5-A2) | 1.6% |
| Linearity / Reportable Range | Demonstrably linear over the specified range for a linear equation (Nonlinearity |
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