(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%) | < 5.0 % CV | Diazyme Lab:- Samples > 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 <5.0% CV of the predicate, with slightly higher CVs for lower concentrations (0.70 mg/L and 0.99 mg/L) at Diazyme Lab, and for some samples at POL sites. However, these were deemed acceptable for substantial equivalence. |
| Precision (Total CV%) | < 5.0 % CV | Diazyme Lab:- Samples > 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 = 0.98673 POL Sites: R² = 0.9872 | Similar |
| Accuracy (Slope) | 0.99 | Diazyme Lab: 0.95353 POL Sites: 0.955 | Similar |
| Accuracy (Intercept) | 0.0877 | Diazyme Lab: 0.09853 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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Pre-market notification Diazyme Cystatin C POC Test
MAR 3 0 2012 K111664
510(k) SUMMARY
Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 12889 Gregg CourtPoway, CA 92064USA |
| Name of Contact Person: | Dr. Abhijit DattaDiazyme Laboratories12889 Gregg CourtPoway, CA 92064 |
| Phone: 858-455-4762Fax: 858-455-2120abhijit.datta@diazyme.com | |
| Name of the Device | Cystatin C POC Test; Cystatin POC Test Control Kit |
| Trade Name | Cystatin C POC Test; Cystatin POC Test Control Kit |
| Common Usual Name | SMART Cystatin C Assay |
| Device Classification Name | Cystatin C POC Assay |
| Product Code | NDY; Test, Cystatin C JJX;Quality Control Material |
| Panel | Clinical Chemistry (75) |
| Submission Type | 510K |
| Regulation Number | 21CFR 862.1225, Creatinine Test System21CFR 862.1660, Quality Control Material |
| Device Class | Class II (Assay)Class I (Control) |
| Predicate Device | Diazyme Cystatin C AssayK093680, K092911 |
| Establishment Registration | 2032900 |
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Executive Summary
Detailed performance characteristics and comparison analysis are given in this filing that demonstrates substantial equivalence of the Cystatin C POC Test Kit to predicate device that is currently being marketed. The performance characteristics of the Cystatin C POC Test Kit are substantially similar to that of the approved predicate device (K093680). Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the Cystatin C POC Test and offers POL users an in vitro diagnostic device system to measure Cystatin C in human blood samples.
Device Description:
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.
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The Diazyme Cystatin C POC Test system thus consists of the following:
- Cystatin C 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.
- Cystatin C POC Test Control Kit. Controls are provided for quality control of . the Cystatin C POC Test.
Equipment needed for Diazyme Cystatin C POC Test:
- SMART Analyzer (K092911). .
Indication (s) for Use:
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.
| Summary of Assay Kit Components(Candidate device) |
|---|
| Reagent 120 DRS cuvette (prefilled)100 mM TrisCl buffer, 0.125% triton |
| Reagent 220 DRS caps (prefilled)Suspension of anti-human Cystatin C polyclonal antibody coated latex particles (<0.5%). |
| Calibrator1 x preprogrammed lot specific RFID card in each kit |
| Control Set1 x 1.0 mL Control 1 (human whole blood based lyophilized, need to reconstitute before use)1 x 1.0 mL Control 2 (human whole blood based lyophilized, need to reconstitute before use) |
PERFORMANCE TESTING SUMMARIES
Precision Study
The precision of the Diazyme Cystatin C POC Test was evaluated according to Clinical and Laboratory Standards Institute (CLSI) EP5-A guideline with the following modifications: In the study, three whole blood specimens containing 1.00 mg/L, 2.70 mg/L, and 6.20 mg/L Cystatin C
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were tested in 2 runs per day with duplicates over 10 working days on three different SMART Analyzers.
The mean value (Mean), standard deviation, within run imprecision and total imprecision CV mg/L are calculated and summarized in the following tables:
| Wholeblood 1Cystatin C | Wholeblood 2Cystatin C | Wholeblood 3Cystatin C | Wholeblood 4Cystatin C | Wholeblood 5Cystatin C | Wholeblood 6Cystatin C | |
|---|---|---|---|---|---|---|
| Total datapoints | 40 | 40 | 40 | 40 | 40 | 40 |
| Mean (mg/L) | 0.988 | 2.720 | 6.1305 | 0.696 | 1.217 | 4.717 |
| SD (mg/L) | 0.0553 | 0.0694 | 0.1353 | 0.0444 | 0.0563 | 0.1148 |
| CV mg/L | 5.6% | 2.6% | 2.2% | 6.4% | 4.6% | 2.4% |
Within Run precision CV%
Total Precision CV%
| Wholeblood 1Cystatin C | Wholeblood 2Cystatin C | Wholeblood 3Cystatin C | Wholeblood 4Cystatin C | Wholeblood 5Cystatin C | Wholeblood 6Cystatin C | |
|---|---|---|---|---|---|---|
| Total datapoints | 40 | 40 | 40 | 40 | 40 | 40 |
| Mean (mg/L) | 0.988 | 2.720 | 6.1305 | 0.696 | 1.217 | 4.717 |
| SD (mg/L) | 0.0577 | 0.0780 | 0.2145 | 0.0478 | 0.0590 | 0.1467 |
| CV mg/L | 5.9% | 2.9% | 3.5% | 6.9% | 4.9% | 3.1% |
Linearity/Reportable Range
Eleven levels of the Cystatin C linearity set were prepared by diluting a whole blood containing about 8 mg/L Cystatin C with saline according to CLSI EP6-A and then were run with Diazyme Cystatin C POC Test Kit in triplicates. After linear regression. the correlation coefficient is R2 = 0.9977. slope is 0.9643, and y intercept is -0.0456. Diazyme Cystatin C POC Test Kit is linear up to 7.65 mg/L. Analytical measuring range (AMR) is 0.30-7.65mg/L.
LoB, LoD, LoQ
The LOB. LOD and LOQ of Diazyme Cystatin C POC Test Kit were determined according to CLSI EP17-A. LOB = 0.045 mg/L; LOD = 0.11 mg/L; LOQ = 0.30 mg/L Cystatin C.
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Analytical specificity
Interference Study
To determine the level of interference from the substances normally present in whole blood, the Diazyme Cystatin C POC Test was used to test two whole blood samples with "low" and "high" Cystatin C concentration spiked with various concentrations of substances following CLSI EP7-A "Interference Testing in Clinical Chemistry": dose-response guidelines.
The common interfering substances had no significant interference up to the concentrations summarized below:
| Interference | Concentration |
|---|---|
| Triglyceride | 1000 mg/dL |
| Ascorbic Acid | 10 mg/dL |
| Bilirubin | 40 mg/dL |
| Bilirubin Conju-gated | 40 mg/dL |
| Rheumatoid Factor | 1000 IU/mL |
| Hemoglobin | 10.0 g/dL |
Comparison studies
Method comparison with predicate device
To demonstrate accuracy, the candidate device was tested with individual samples and the results compared to predicate device (K093680) using CLSI EP9-A2: Method Comparison and Bias Estimation Using patient samples as a guideline. The method comparison study was performed internally at Diazyme laboratories and externally at three POL sites.
Internal method comparison
Paired human whole blood-serum samples (venous whole blood and plasma from the same individual) were tested for comparison. The whole blood samples were tested with the Diazyme Cystatin C POC Test on SMART analyzer and the correspondent plasma samples were tested with predicate Assay (K093680) on Hitachi 917. A total of fifty five (55) EDTA whole blood specimens were tested with Diazyme Cystatin C POC Test. The correspondent plasma samples were tested with Diazyme Cystatin C on Hitachi 917 analyzer.
Regression results are summarized in the following table:
| N | 55 |
|---|---|
| Slope | 0.9535 |
| Intercept | 0.0958 |
| R2 | 0.9867 |
External method comparison
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120 whole blood samples were tested at three POL sites by intended users. Each site ran 40 whole blood samples using SMART analyzers. The corresponding one hundred and twenty (120) plasma specimens were tested on Hitachi 917 with predicate device.
| Site 1 | Site 2 | Site 3 | All 3 sites | |
|---|---|---|---|---|
| N | 40 | 40 | 40 | 120 |
| Slope | 0.9967 | 0.9049 | 0.9617 | 0.955 |
| Intercept | 0.1058 | 0.0731 | 0.0352 | 0.0723 |
| R2 | 0.9902 | 0.9902 | 0.9937 | 0.9872 |
Regression analysis of the results obtained from the three POL sites is summarized as follows:
Expected values/ Reference range:
To verify the transferability of the reference interval from the predicate device, whole blood samples from 126 apparently healthy adults with age of 19-63 were tested using the Diazyme Cystatin C SMART assay according to CLSI C28-A3 guideline. The expected normal range is 0.46 to 1.06 mg/L in 95% of the population tested.
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Substantial Equivalence Table
Indications for Use
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| The Diazyme Cystatin C Assay is an in-vitro diagnostic test for the quantitativedetermination of Cystatin C in serum orplasma by latex enhancedimmunoturbidimetric method. Themeasurement of Cystatin C is used as anaid in the diagnosis and treatment ofrenal disease. | Diazyme Cystatin C Point-of Care(POC) test reagents are intended for usewith the SMART analyzer for thequantitative determination of Cystatin Cin venous whole blood by latexenhanced immunoturbidimetric method.The measurement of Cystatin C is usedas an aid in the diagnosis and treatmentof renal disease. For in vitro DiagnosticUse Only. | Similar |
Principle
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| Diazyme Cystatin C assay is based on alatex enhanced immunoturbidimetricassay. Cystatin C in the sample binds tothe specific anti-Cystatin C antibody,which is coated on latex particles, andcauses agglutination. The degree of theturbidity caused by agglutination can bemeasured optically and is proportionalto the amount of Cystatin C in thesample. | Diazyme Cystatin C assay is based on alatex enhanced immunoturbidimetricassay. Cystatin C in the sample binds tothe specific anti-Cystatin C antibody,which is coated on latex particles, andcauses agglutination. The degree of theturbidity caused by agglutination can bemeasured optically and is proportionalto the amount of Cystatin C in thesample. | Same |
Test Objective
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| For the in vitro quantitativedetermination of human Cystatin C. | For the in vitro quantitativedetermination of human Cystatin C. | Same |
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Type of Test
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| Quantitative | Quantitative | Same |
Methodology
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| ------------------- | ------------------ | ------------- |
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| Latex enhanced immunoturbidimetricmethod | Latex enhanced immunoturbidimetricmethod | Same |
|---|---|---|
| ---------------------------------------------- | ---------------------------------------------- | ------ |
Antibodies
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| Latex particles coated with anti-humanCystatin C chicken polyclonalantibodies | Latex particles coated with anti-humanCystatin C chicken polyclonalantibodies | Same |
Specimen
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| 3µL Human serum or plasma. | 20 µL Human venous whole blood. | Different |
Product Type
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| Assay reagent kit, calibrator kit, qualitycontrol kit | Assay reagent kit, kit specific RFIDcalibration card, quality control kit | Similar |
Performance
.
| Predicate K093680 | Candidate device |
|---|---|
| Measuring Range: 0.27 to 7.8 mg/L | Measuring Range: 0.30 to 7.65 mg/L |
| Precision:Within: < 5.0 % CVTotal: < 5.0 % CVAccuracy:Correlation Coefficient: 0.99Slope/Intercept: 0.99/0.0877 | Precision at Diazyme:The CV for samples above 1.0 mg/L ranged from2.2% to 4.9%. Samples with concentrations of 0.70mg/L, and 0.99 mg/L were also tested and the CVranged from 6.9% to 5.6%.Precision at 3 POL sites:The CV for samples above 1.0 mg/L ranged from2.6% to 8.0%. Samples with concentrations of0.55mg/L, and 0.93 mg/L were also tested and the CVranged from 9.1% to 5.3%.Accuracy at Diazyme:N =55Correlation Coefficient: 0.9867Slope/Intercept: y = 0.9535/0.0985 |
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| Accuracy at 3 POL sites: |
|---|
| N = 120 |
| Correlation Coefficient: 0.9872 |
| Slope/Intercept: y = 0.955/0.0732 |
Calibrator Comparison
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| Separately packaged calibrator kit. Usersteps needed to use calibrators.The instrument calculates the Cystatin Cconcentration of a patient specimen byinterpolation of the obtained signal on a6-point calibration curve | Each kit has individual lot specificRFID preprogrammed calibration card.User steps limited to insertion inSMART analyzer.The instrument calculates the CystatinC concentration of a patient specimenby use of a lot specific calibrationcurve that is stored in an RFID cardprovided with each Cystatin C SMARTtest kit. | Different |
Control Comparison
| Predicate K093680 | Candidate device | Equivalency |
|---|---|---|
| Separately packaged quality control kitdesigned for specific assay | Separately packaged quality control kitdesigned for specific assay | Same |
| Liquid stable ready to use | Lyophilized powder, need toreconstitute with distilled water | Different |
.
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Rationale for Considering the Device Substantially Equivalent to Devices Approved for Inter-state Commerce
Diazyme Cystatin C Assay (K093680) was selected for method comparison. The reagents used for the POC Test are similar to the predicate and were used to develop the application (parameter) for the SMART Analyzer. The only difference is the addition of detergent Triton-100 (0.125%) is to Reagent R1. The similarity and differences for the predicate reagent versus the POC Test reagents are given in the table below.
| Predicate K093680 | Candidate device |
|---|---|
| Kit can be used on automated chemistryanalyzers using validated parameters | Kit can ONLY be used with SMARTanalyzers |
| Reagent 1 | Reagent 1 |
| 1 bottle | 20 DRS cuvette (prefilled) with reagent R1 |
| • 100 mM TrisCl buffer | • 100 mM TrisCl buffer |
| • 0.125% Triton-100 | |
| Reagent 2 | Reagent 2 |
| 1 bottle | 20 DRS caps (prefilled) |
| • Suspension of anti-human Cystatin Cpolyclonal antibody coated latexparticles (< 0.5%) | • Suspension of anti-human Cystatin Cpolyclonal antibody coated latexparticles (< 0.5%). |
| Calibrator set | Calibrator |
| 5 x 1.0 mL Calibrator 1-5 | 1 x preprogrammed lot specific RFID card ineach kit |
| Control Set | Control Set |
| 1 x 1.0 mL Control 1(buffer based liquid, readto use) | 1 x 1.0 mL Control 1( human blood basedmatrix, lyophilized, need to reconstitute beforeuse) |
| 1 x 1.0 mL Control 2(buffer based liquid, readto use) | 1 x 1.0 mL Control 2( human blood basedmatrix lyophilized, need to reconstitute beforeuse) |
Summary of Assay Kit Components
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract human figure, represented by three curved lines, which is meant to symbolize health and well-being.
10903 New Hampshire Avenue Silver Spring, MD 20993
Diazyme Laboratories, Inc. c/o Abhijit Datta, PhD. 12889 Gregg Court Poway, CA 92064
MAR 3 0 2012
Re: K111664
Trade Name: Diazyme Cystatin C POC Test Kit; Diazyme Cystatin C POC Test Control Kit Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: NDY, JJX Dated: March 15, 2012
Received: March 19, 2012
Dear Dr. Datta:
We have reviewed your Section 510(k) premarket notification of intent to market the . device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
N.
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (If Known): K111664
Device Name: Diazyme Cystatin C POC Test Kit; Diazyme Cystatin C POC Test Control Kit
Indications for Use:
Diazyme Cystatin C Point-of Care (POC) test reagents are intended for use with the SMART ana-Draer 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
KIII KKU 210(K)
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§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.