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510(k) Data Aggregation
(233 days)
The Diazyme Glycated Serum Protein POC Test Kit is intended for the quantitative determination of glycated serum proteins (GSP; fructosamine) in serum. Fructosamine is representative of blood glucose levels over the course of 2-3 weeks. The measurement of glycated serum proteins is useful for monitoring diabetic patients. For in vitro diagnostic use only.
Fructosamine is formed due to a non-enzymatic Maillard reaction between glucose and amino acid residues of serum proteins. It is reported in medical literature that 80% of measured glycated serum proteins are glycated albumins. In diabetic patients, elevated blood glucose levels correlate with increased fructosamine formation. Glycated serum proteins (GSP; fructosamine) are a medium term indicator of diabetic control (2-3 weeks).
The Diazyme Glycated Serum Protein POC Assay uses proteinase K to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme's specific fructosamiase™, a microorganisms originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield peptide fragments (PF) or amino acids, glucosone and H2O2. The H2O2 released is measured by a colorimetric Trinder end-point reaction. The absorbance at 546 nm is proportional to the concentration of glycated serum proteins. The SMART analyzer calculates the GSP concentrations of patient serum specimens by use of a lot specific calibration curve. The lot specific curve is represented in a Calibration card (RFID) provided with each GSP POC Test Kit.
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 40ul of sample to the DRS cuvette prefilled with R1 containing proper buffer. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 546nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and lot specific calibration curve.
The Diazyme GSP POC Test Kit system thus consists of the following:
- . GSP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
The provided document describes the Diazyme Glycated Serum Protein POC Test Kit and its performance characteristics. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for precision or linearity. However, it presents the performance data in a way that implies these are the achieved results for demonstrating substantial equivalence. The predicate device's performance is listed, and the new device's performance is compared for similarity.
| Performance Metric | Acceptance Criteria (Implied from Predicate/Good Practice) | Reported Device Performance (Diazyme GSP POC Test Kit) |
|---|---|---|
| Linearity | Similar to predicate (up to 1354 µmol/L) | 61 to 1348 µmol/L (Linear from 2 to 1348 µmol/L tested) |
| Precision (Within %CV) | Less than 2.0% CV (predicate) | ≤ 6.1% CV (Serum Level 1) |
| ≤ 1.5% CV (Serum Level 5) | ||
| Precision (Total %CV) | Less than 2.0% CV (predicate) | ≤ 5.6% CV (Serum Level 1) |
| ≤ 1.8% CV (Serum Level 5) | ||
| Accuracy (Correlation Coefficient) | Similar to predicate (0.9966) | 0.9975 |
| Accuracy (Slope) | Similar to predicate (0.9542) | 0.9737 |
| Accuracy (Intercept) | Similar to predicate (14.57 µmol/L) | 0.6859 µmol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size for Comparison Study: 54 serum specimens
- Test Set Sample Size for Precision Study: 5 serum samples, each tested 80 times (2 runs/day, duplicates, over 20 working days). This implies a total of 400 individual measurements (5 samples * 80 measurements/sample).
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective for the device's performance characterization, as it describes actively testing samples with the new device and comparing them to results from the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in-vitro diagnostic assay that measures a biomarker. The "ground truth" for the test set is established by the well-characterized predicate device (Diazyme Glycated Serum Protein Assay on Hitachi 917 analyzer). No human experts are used to establish a subjective "ground truth" for a diagnostic image or interpretation.
4. Adjudication Method for the Test Set
Not applicable. As this is a quantitative measurement against a predicate, there is no expert adjudication process. The comparison is statistical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a point-of-care in-vitro diagnostic test, not an imaging device or AI-assisted diagnostic tool that involves human reader interpretation. Therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance data presented (Linearity, Precision, Interference, and Comparison Studies) are all for the Diazyme GSP POC Test Kit operating in a standalone capacity, measuring GSP levels in serum samples without human intervention in the result generation itself (beyond sample loading). The SMART Analyzer with its RFID card is essentially the "algorithm" that interprets the optical readings and calculates the GSP concentration.
7. The Type of Ground Truth Used
The ground truth used for the comparison study is the measurement result from the legally marketed predicate device (Diazyme Glycated Serum Protein Assay on Hitachi 917 analyzer (K110188)). For the linearity, precision, and interference studies, the "ground truth" is based on the known concentrations of the prepared samples or spiked substances.
8. The Sample Size for the Training Set
Not applicable. This device is an analytical instrument and reagent kit, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and optical detection. The RFID card contains a "lot specific calibration curve," which is developed by the manufacturer. While this involves data, it's not a "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8. The "calibration curve" stored on the RFID card is established through a calibration process using known standards (calibrators) to ensure accurate measurements across the reportable range. This is a standard procedure for IVD assays.
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(115 days)
The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP POC control set is intended for use as quality controls for the Diazyme hsCRP POC Test Kit. For in vitro diagnostic use only.
Diazyme's hsCRP POC Test Kit is based on a latex enhanced immunoturbidimetric assay on Diazyme's SMART analyzer. Agglutination occurs when an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles. This agglutination is detected as an absorbance change (700 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The instrument calculates the CRP concentration of patient specimen by use of a lot specific calibration curve that is stored in an RFID card provided with each hsCRP POC kit. The RFID card is inserted in the SMART analyzer and is needed for every single run.
Diazyme hsCRP POC Control Kit is intended for use as quality controls for the Diazyme hsCRP POC Test Kit and is packaged separately. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. OC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists.
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The Diazyme hsCRP POC Test Kit system thus consists of the following:
- hsCRP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
- hsCRP POC Control Kit. Controls are provided for quality control of the . hsCRP POC Assay.
Equipment needed for Diazyme hsCRP POC Test Kit:
• SMART Analyzer (K092911).
Kit components
(Candidate device)
Reagent 1
40 DRS cuvette (prefilled)
- · 100 mM TrisCl buffer
Reagent 2
40 DRS caps (prefilled)
- Suspension of anti-human CRP polyclonal antibody coated latex particles . (
The document describes the Diazyme hsCRP POC Test Kit, an in vitro diagnostic device for quantitative determination of C-reactive protein (CRP) in human venous whole blood. The device is intended for the detection and evaluation of inflammatory disorders, associated diseases, infection, and tissue injury.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines several performance tests with specific acceptance criteria and the observed results.
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Internal) | Within-run and total CV% (specific values not explicitly stated, but generally low for diagnostic devices) | Within Run CV%: |
- 0.813 mg/L: 9.62%
- 3.186 mg/L: 2.83%
- 12.560 mg/L: 1.79%
Total Precision CV%: - 0.813 mg/L: 8.17%
- 3.186 mg/L: 3.09%
- 12.560 mg/L: 2.12% |
| Precision (External) | Within-run and total CV% (specific values not explicitly stated, but generally low for diagnostic devices) | Within Run CV% (POL sites): - 0.798 mg/L: 4.67%
- 4.796 mg/L: 7.02%
- 0.758 mg/L: 9.04%
- 17.796 mg/L: 4.18%
- 7.780 mg/L: 5.43%
- 18.725 mg/L: 5.02%
Total CV% (POL sites): - 0.798 mg/L: 8.58%
- 4.796 mg/L: 7.37%
- 0.758 mg/L: 8.13%
- 17.796 mg/L: 4.02%
- 7.780 mg/L: 5.24%
- 18.752 mg/L: 4.78% |
| Linearity | (Implicitly to support AMR) | Linearity data and LOQ data support Analytical Measuring Range (AMR) of 0.47 mg/L to 23.0 mg/L. |
| Limit of Detection (LOD) | (Implicitly to determine lower detection limit) | LOD is 0.15 mg/L |
| Limit of Quantitation (LOQ) | (Implicitly to determine lower quantitation limit) | LOQ is 0.47 mg/L |
| Analytical Specificity (Interference) |
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(116 days)
Diazyme's HCY POC Test Kit is intended to be used with the SMART analyzer in a Point-of-Care setting for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For in vitro diagnostic use only.
Diazyme HCY POC Test Kit contains reagents intended for use with the SMART analyzer for the quantitative determination of Homocysteine (HCY) in human serum or plasma. Diazyme HCY POC Test is based on a novel enzyme cycling method as published in the Journal of Clinical Chemistry. In this assay, oxidized HCY is first reduced to free HCY which then reacts with a co-substrate, S-adenosylmethionine (SAM) catalyzed by a HCY S-methyltransferase to form methionine (Met) and S-adenosylhomocysteine (SAH). SAH is assessed by coupled enzyme reactions including SAH hydrolase, adenosine (Ado) deaminase and glutamate dehydrogenase, wherein SAH is hydrolyzed into adenosine (Ado) and HCY by SAH hydrolase. The formed HCY that is originated from the co-substrate SAM is cycled into the HCY conversion reaction by HCY S-methyltransferase. This forms a co-substrate conversion product-based enzyme cycling reaction system with signification of detection signals. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversion of NADH to NAD+. The concentration of HCY in the sample is indirectly proportional to the amount of NADH converted to NAD+ (ΔA340mm).
The Diazyme HCY POC Test system thus consists of the following:
- HCY POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
- HCY POC Test Control Kit. Controls are provided for quality control of the . HCY POC Test.
Here’s an analysis of the acceptance criteria and study data for the Diazyme HCY POC Test, based on the provided document:
Acceptance Criteria and Device Performance for Diazyme HCY POC Test
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (Manufacture site) | "These results meet precision criteria." (Implied generally low CV%) | Within CV%: |
- 7.5 µmol/L HCY: 3.2%
- 11.8 µmol/L HCY: 1.8%
- 29.0 µmol/L HCY: 2.8%
Total CV%: - 7.5 µmol/L HCY: 3.4%
- 11.8 µmol/L HCY: 3.5%
- 29.0 µmol/L HCY: 3.3% |
| Precision (POL sites - 1) | "The results indicated good precision..." (Implied generally low CV%) | POL 1 (Sample 1): Within CV% 3.1%, Total CV% 5.2%
POL 1 (Sample 2): Within CV% 2.8%, Total CV% 3.7%
POL 1 (Sample 3): Within CV% 2.8%, Total CV% 4.1%
POL 1 (Sample 4): Within CV% 3.5%, Total CV% 6.0%
POL 1 (Sample 5): Within CV% 2.6%, Total CV% 3.2% |
| Precision (POL sites - 2) | "a CV% of less than 8% was obtained at the three POL sites." for 9 serum samples ranging from 10.26 µmol/L to 42.73 µmol/L. | Site 1: - Sample 1: Total CV 7.0%
- Sample 2: Total CV 5.3%
- Sample 3: Total CV 6.4%
Site 2: - Sample 1: Total CV 6.6%
- Sample 2: Total CV% 5.5%
- Sample 3: Total CV% 4.4%
Site 3: - Sample 1: Total CV% 6.0%
- Sample 2: Total CV% 6.8%
- Sample 3: Total CV% 5.5% |
| Linearity/Reportable Range | Implied acceptable linearity and range. Based on R2, often >0.99 for diagnostic assays. | Linear from 3 - 50 µmol/L.
Regression equation: Recovered HCY = 0.9749 * Expected HCY + 0.751
Correlation coefficient (R2): 0.9992 |
| Traceability | Traceable to a higher-order standard. | HCY POC Test calibration is traceable to the higher order NIST SRM 1955. |
| Stability | Implied acceptable stability duration. | Real-time data showed stability for at least 10 months at 2-8℃ storage. (Testing is ongoing). |
| LoB, LoD, LoQ | Distinct, measurable limits. | LoB = 0.06 µmol/L
LoD = 0.32 µmol/L
LoQ = 3.00 µmol/L |
| Interference | "produced less than 10% deviation" for common endogenous substances at specified concentrations. | All listed endogenous substances (Ascorbic Acid, Bilirubin, Hemoglobin, Triglyceride, Glutathione, Methionine, Cysteine, Pyruvate, Cystathionine, Hydroxylamine, Carbamezapine, Methotrexate, Phenytoin, 6-azauridine triacetate, S-adenosyl-methionine, Carbamezapine-10, 11-epoxide, Ethosuximide, Primidone, Valporic Acid, Sodium Nitrate) produced less than 10% deviation at the specified concentrations. |
| Method Comparison (Internal) | Strong correlation and agreement with predicate device (Diazyme HCY Two Reagent Enzymatic Assay on Olympus AU400). Implied R > 0.95. | n: 74
Slope: 0.9612
Intercept: 0.5246
Correlation coefficient (R): 0.9696
Range of values: 4.17-49.50 µmol/L |
| Method Comparison (External) | Strong correlation and agreement with predicate device at POL sites. Implied R2 > 0.95. | All 120 samples combined:
Slope: 1.0552
Intercept: -0.8860
R2: 0.9765
Range: 3.88-49.86 µmol/L (across sites) - Site 1: Slope 1.0890, Intercept -0.7438, R2 0.9830
- Site 2: Slope 1.0041, Intercept -0.6251, R2 0.9645
- Site 3: Slope 1.0600, Intercept -1.1564, R2 0.9819 |
| Matrix Comparison | No significant matrix effect between serum, EDTA plasma, and Li Heparin plasma. | EDTA plasma: Slope = 1.0197, R = 0.9889
Li Heparin plasma: Slope = 0.9632, R = 0.99
Conclusion: No matrix effect between serum, EDTA plasma and Li Heparin Plasma. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Manufacture site): 40 points per HCY level (3 levels). Data provenance is internal (manufacturer site). Prospective data collection for this internal study.
- Precision (POL sites - 1): 20 points for each of 5 samples. Data provenance is external (three Physician Office Laboratories - POLs). Prospective data collection for this external study.
- Precision (POL sites - 2): 20 points for each of 3 samples per site, across 3 sites. Data provenance is external (three POLs with multiple users). Prospective data collection for this external study.
- Linearity/Assay Reportable Range: Ten levels of linearity set, tested in triplicate. Data provenance is internal (manufacturer site). Prospective data collection.
- Interference: 12μM and 29μM HCY serum samples spiked with various concentrations of interferents. Data provenance is internal (manufacturer site). Prospective data collection.
- Method Comparison (Internal): 74 individual serum samples. Data provenance is internal (manufacturer site). Likely prospective/retrospective (spiked samples indicate some manipulation).
- Method Comparison (External): 120 serum specimens total (40 samples at each of three POL sites). Data provenance is external (three POL sites). Prospective data collection.
- Matrix Comparison: 40 sample sets (serum/EDTA plasma/Li Heparin). Data provenance is internal (manufacturer site). Prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (a quantitative in-vitro diagnostic assay) does not typically use human experts to establish "ground truth" for the test set in the way an imaging AI algorithm would. Instead, the "ground truth" for the test samples is established by:
- Reference Methods: The predicate device itself (Diazyme HCY Two Reagent Enzymatic Assay on Olympus AU400 cleared under K071971) serves as the reference method for comparison studies, implicitly providing the "ground truth" values for patient samples. The predicate device itself would have been validated against a higher standard.
- Known Concentrations: For studies like linearity, LoB/LoD/LoQ, and interference, samples with precisely known concentrations of HCY or interfering substances are prepared according to recognized laboratory standards (e.g., CLSI guidelines).
- NIST SRM 1955: For calibrator traceability, the device is linked to a National Institute of Standards and Technology (NIST) Standard Reference Material, which represents a highly accurate and reliable "ground truth" for homocysteine concentration.
Therefore, no information on the number or qualifications of experts establishing ground truth in the context of clinical interpretation or annotations is applicable or provided.
4. Adjudication Method for the Test Set
Not applicable. As a quantitative in-vitro diagnostic test, "adjudication" in the sense of resolving conflicting interpretations (like in imaging studies) is not performed. The results are numerical values that are compared against a reference method or known concentrations.
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 an in-vitro diagnostic device for quantitative bodily fluid analysis, not an imaging AI or decision-support tool for human interpretation. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are essentially "standalone" performance evaluations of the device (HCY POC Test Kit + SMART analyzer). The device provides a quantitative result directly, without requiring human interpretation of raw data or human modification of the algorithm's output for its primary function. The users (nurses, office assistants) described in the POL precision studies are operating the device, but their "performance" isn't being measured in terms of their diagnostic accuracy, but rather their ability to correctly perform the test yielding consistent results.
7. The Type of Ground Truth Used
The ground truth used depends on the specific performance characteristic being evaluated:
- For Precision, Linearity, LoB/LoD/LoQ: Samples with precisely known concentrations of HCY, prepared in the laboratory or from certified reference materials (like NIST SRM 1955 for traceability).
- For Method Comparison: The values obtained from the predicate device (Diazyme HCY Two Reagent Enzymatic Assay on an Olympus AU400, K071971) were used as the reference "ground truth" for comparison.
- For Interference: Samples with known HCY concentrations spiked with known concentrations of suspected interfering substances.
8. The Sample Size for the Training Set
This document describes a premarket approval (510(k)) submission for an in-vitro diagnostic assay kit. Such submissions typically detail validation studies for the finished product, not the development or training of an algorithm in the machine learning sense. The "SMART analyzer" uses an RFID card with a preprogrammed calibration curve, which is derived from testing 5 levels of calibrators with the reagents.
- The training set for the calibration curve programming on the RFID card involves testing "5 levels of calibrators used in the predicate device (K071971)" with the Diazyme HCY POC Test reagents on SMART analyzers. The exact number of replicates or runs during this programming phase is not specified beyond "mean of absorbance change."
9. How the Ground Truth for the Training Set Was Established
The "ground truth" for establishing the calibration curve (which is the "training set" in a functional sense for this IVD) is established by using:
- Reference Diazyme Homocysteine calibrator values (K071971): These calibrators themselves would have assigned values traceable to higher-order standards.
- NIST SRM 1955: The overall calibration is tied to this higher-order standard.
The process involves testing these known calibrators on the SMART analyzer to obtain absorbance changes, and then programming a curve that correlates these absorbance changes to the known HCY concentrations, which constitutes the "ground truth" for the device's measurement function.
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(290 days)
Diazyme Cystatin C Point-of Care (POC) test reagents are intended for use with the SMART analyzer for the quantitative determination of Cystatin C in venous whole blood by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. For in vitro Diagnostic Use Only.
The Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Cystatin C POC Test. For in vitro Diagnostic Use Only.
Diazyme Cystatin C POC Test Kit contains reagents intended for use with the SMART analyzer for the quantitative determination of Cystatin C (Cys C) in human venous whole blood samples. Measurement of Cystatin C can assist in the assessment of renal transplantation status, monitoring GFR in nephrotoxic drug therapy, and monitoring GFR in acute and chronic kidney diseases including diabetic nephropathy. Cystatin C POC Test reagents are similar to the predicate Diazyme Cystatin C assay reagents (K093680). The similarities and differences in composition and format are noted in Table 1 below. The Cystatin C POC Test is based on a latex enhanced immunoturbidimetric assay. Cystatin C in the venous whole blood sample binds to the specific anti-Cystatin C antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Cystatin C in the venous whole blood sample. The Cystatin C concentration is expressed as mg/L Cystatin C by use of a lot specific calibration curve that is stored in an RFID card provided with each SMART test kit.
Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Diazyme Cystatin C POC Test and is packaged separately. The controls are made from human venous whole blood and are in a lyophilized (freeze-dried) state. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. QC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists.
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuyette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for venous whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The Diazyme Cystatin C POC Test is a device intended for the quantitative determination of Cystatin C in venous whole blood using a latex-enhanced immunoturbidimetric method with the SMART analyzer. The measurement of Cystatin C aids in the diagnosis and treatment of renal disease.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" but presents performance characteristics that were evaluated for substantial equivalence to a predicate device. The performance of the Diazyme Cystatin C POC Test is compared against a predicate device (Diazyme Cystatin C Assay, K093680). The table below summarizes the reported performance for the candidate device, which implicitly serves as the performance values that met the substantial equivalence requirements.
| Performance Metric | Predicate Device (K093680) | Candidate Device (Diazyme Cystatin C POC Test) | Study Findings |
|---|---|---|---|
| Measuring Range | 0.27 to 7.8 mg/L | 0.30 to 7.65 mg/L | Similar |
| Precision (Within-Run CV%) | 1.0 mg/L: 2.2% to 4.9% |
- Samples 0.70 mg/L & 0.99 mg/L: 5.6% to 6.9% | The reported CVs for the candidate device are generally within or close to the 1.0 mg/L: 2.2% to 4.9%
- Samples 0.70 mg/L & 0.99 mg/L: 5.6% to 6.9%
3 POL Sites: - Samples > 1.0 mg/L: 2.6% to 8.0%
- Samples 0.55 mg/L & 0.93 mg/L: 5.3% to 9.1% |
| Accuracy (Correlation Coefficient R²) | 0.99 | Diazyme Lab: R² = 0.9867
3 POL Sites: R² = 0.9872 | Similar |
| Accuracy (Slope) | 0.99 | Diazyme Lab: 0.9535
3 POL Sites: 0.955 | Similar |
| Accuracy (Intercept) | 0.0877 | Diazyme Lab: 0.0985
3 POL Sites: 0.0732 | Similar |
| Linearity/Reportable Range (R²) | Not specified | R² = 0.9977 (up to 7.65 mg/L) | Demonstrated strong linearity. |
| LoB | Not specified | 0.045 mg/L | Established. |
| LoD | Not specified | 0.11 mg/L | Established. |
| LoQ | Not specified | 0.30 mg/L | Established, defining the lower end of the AMR. |
| Interference | Not specified | No significant interference from common substances up to specified concentrations. | Demonstrated analytical specificity. |
| Expected/Reference Range | Not specified | 0.46 to 1.06 mg/L (in 95% of healthy adults) | Confirmed transferability of reference interval. |
2. Sample 사이즈 used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision Study:
- Sample Size: 6 whole blood specimens were tested. Each specimen was run in duplicates, twice a day, over 10 working days on three different SMART Analyzers. This totals (2 runs/day * 2 duplicates/run * 10 days * 3 analyzers) = 120 data points per specimen, but the table reports "Total data points: 40" per specimen for within-run and total precision, implying 40 measurements per specimen over the study period (perhaps per analyzer or across all analyzers).
- Data Provenance: The study was conducted internally at Diazyme Laboratories, implying internal prospective testing of samples. No specific country of origin is mentioned beyond Diazyme's location in Poway, CA, USA.
- Linearity Study:
- Sample Size: Eleven levels of Cystatin C concentrations were prepared from a whole blood sample and run in triplicates.
- Data Provenance: Internal to Diazyme Laboratories.
- LoB, LoD, LoQ:
- Sample Size: Not explicitly stated but usually involves multiple replicates of blank and low-concentration samples.
- Data Provenance: Internal to Diazyme Laboratories.
- Interference Study:
- Sample Size: Two whole blood samples ("low" and "high" Cystatin C) spiked with various concentrations of interfering substances.
- Data Provenance: Internal to Diazyme Laboratories.
- Method Comparison with Predicate Device (Accuracy Study):
- Internal Method Comparison:
- Sample Size: Fifty-five (55) paired human whole blood-serum samples (venous whole blood and plasma from the same individual).
- Data Provenance: Conducted internally at Diazyme Laboratories, likely prospective.
- External Method Comparison:
- Sample Size: One hundred and twenty (120) whole blood samples (40 samples per site) tested at three Point-of-Care (POL) sites. Corresponding plasma specimens (120) were tested with the predicate device.
- Data Provenance: Conducted externally at three POL sites by intended users, implying prospective testing in real-world settings.
- Internal Method Comparison:
- Expected Values/Reference Range Study:
- Sample Size: 126 apparently healthy adults.
- Data Provenance: Whole blood samples were tested using the Diazyme Cystatin C SMART assay, likely collected prospectively for this study, though the specific origin is not stated beyond Diazyme. Age range of participants was 19-63.
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 device is an in vitro diagnostic (IVD) test for quantitative determination of a biomarker (Cystatin C). The "ground truth" for such devices is typically established through reference methods or established assays, rather than expert consensus on interpretive tasks like in imaging.
- For the accuracy/method comparison studies (test set): The predicate device, Diazyme Cystatin C Assay (K093680), run on a Hitachi 917 analyzer, served as the reference method or "ground truth" comparator for the comparison studies. The performance of the predicate device itself would have been established against a recognized gold standard during its own clearance process.
- Number/Qualifications of Experts: The document does not specify experts establishing ground truth in the traditional sense of clinical interpretation. The "experts" involved would be the clinical laboratory professionals operating the predicate device and the new device. Their qualifications are not detailed but are assumed to be standard for clinical laboratory practice.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. For quantitative diagnostic tests measuring a biomarker, adjudication methods typically used for qualitative or interpretive tasks (like imaging analysis) are not relevant. The "ground truth" is determined by the result of the reference method (predicate device) and direct comparison of quantitative values. Statistical methods (e.g., regression analysis) are used to assess agreement.
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 an in vitro diagnostic device, not an AI-assisted diagnostic imaging or interpretive aid. It directly measures a biomarker. The studies involved comparing the performance of the new device to a predicate device, not the improvement of human reader performance with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies present the standalone performance of the Diazyme Cystatin C POC Test System. The device provides a quantitative result for Cystatin C. The performance metrics reported (precision, linearity, accuracy, LoB, LoD, LoQ, interference) reflect the performance of the device system (reagents + SMART analyzer) itself, without direct human cognitive interpretation of the final result for diagnostic purposes. Humans operate the device and interpret the numerical output in the context of clinical guidelines, but the "performance" described is that of the automated measurement system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Method Comparison Studies: The "ground truth" was established by comparison to a legally marketed predicate device (Diazyme Cystatin C Assay, K093680) run on a Hitachi 917 analyzer. This is a common approach for demonstrating substantial equivalence for new IVD devices.
- Other Performance Studies (Precision, Linearity, LoB/LoD/LoQ, Interference): These studies assess the intrinsic analytical performance of the device against predefined analytical standards (e.g., CLSI guidelines), often using prepared control materials or spiked samples where the "true" concentration is known or assumed from the preparation.
8. The sample size for the training set
This document describes a pre-market notification (510(k)) for a traditional IVD device, not a machine learning or AI-driven algorithm. Therefore, the concept of a "training set" in the context of AI model development is not directly applicable here.
The device's calibration curve is established using a lot-specific RFID card provided with each kit. This implies a calibration process performed by the manufacturer, which might involve a set of calibrators, but it's not a "training set" for an AI algorithm.
9. How the ground truth for the training set was established
Not applicable, as no AI/machine learning training set is described for this conventional IVD device. The calibration for the device is performed using a lot-specific calibration curve stored on an RFID card. The accuracy of this calibration would be verified during manufacturing and quality control processes.
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