(30 days)
The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.
The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.
The K-ASSAY® Ferritin (2nd Gen.) assay is a latex enhanced immuno-turbidimetric assay for the quantitative in vitro determination of ferritin levels in serum and plasma (EDTA and heparin) samples.
The K-ASSAY® Ferritin (2nd Gen.) consists of two reagents. Reagent 1 contains HEPES buffer solution (50 mmol/L) and Reagent 2 contains HEPES buffer solution (50 mmol/L) and a solution of latex suspension with mouse monoclonal anti-human ferritin antibodies. Both reagents also contain less than 0:01 w/v% of sodium azide as a preservative.
The K-ASSAY® Ferritin Calibrators (2nd Gen.) are liquid stable products consisting of a human serum matrix and known quantities of human ferritin at 6 levels ranging from 0 -1,000 ng/mL (0, 25, 250, 500, 750, 1,000 ng/mL). The calibrators also contain less than 0.1 w/v% of sodium azide as a preservative.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Precision | Between-lot CV% < 1% | Group 1: 0.99%, Group 2: 0.37%, Group 3: 0.39%, Group 4: 0.42% (All < 1%) |
| Linearity | Linear throughout the claimed measuring range of 5 - 1,000 ng/mL | Slope: 0.9999 (95% CI: 0.9976 to 1.0022), Intercept: 0.1249 (95% CI: -0.9049 to 1.1546), Demonstrated to be linear with <10% deviation |
| Traceability | Calibrator values traceable to WHO 2nd International Ferritin Standard, lot 80/578 | Ferritin values assigned to calibrators are traceable to WHO 2nd International Ferritin Standard, lot 80/578 |
| Stability (Reagent) | Unopened shelf life: 1 year (2-8°C) | 1 year (2-8°C) |
| Open-vial stability: 1 month (2-8°C) | 1 month (2-8°C) | |
| On-board stability: 1 month | At least 1 month | |
| Stability (Calibrator) | Unopened shelf life: 1 year (2-8°C) | 1 year (2-8°C) |
| Open-vial stability: 1 month (2-8°C) | 1 month (2-8°C) | |
| Detection Limits (LoB) | Claimed Value 1.039 ng/mL | Reported result: 1.039 ng/mL (matches claimed value) |
| Detection Limits (LoD) | Claimed Value 1.825 ng/mL | Reported result: 1.825 ng/mL (matches claimed value) |
| Detection Limits (LoQ) | Claimed Value 5.0 ng/mL | Reported result: 5.0 ng/mL (matches claimed value) |
| Analytical Specificity (Interference) | No significant interference with specified substances within ±10% deviation | Bilirubin C (20 mg/dL), Bilirubin F (20 mg/dL), Hemoglobin (500 mg/dL), Rheumatoid Factor (1,000 IU/mL), Sodium Citrate (1,000 mg/dL), Sodium EDTA (500 mg/dL), Sodium Fluoride (1,000 mg/dL), Sodium Heparin (20 mg/dL), Turbidity (2,000 FTU) all showed no significant interference |
| Analytical Specificity (Antigen Excess/Prozone) | Measured value does not decrease to less than 1,000 ng/mL up to 80,000 ng/mL | Up to 80,000 ng/mL, the measured value does not decrease to less than 1,000 ng/mL |
| Method Comparison (vs. Predicate) | Favorable regression analysis indicating substantial equivalence | y = 1.0057x + 0.0968; Slope 95% CI: 1.0022 to 1.0092; Y-Intercept 95% CI: -1.1690 to 1.3625 |
| Matrix Comparison (Serum vs. EDTA Plasma) | Favorable regression analysis indicating acceptability | y = 1.0199x - 0.0813; Slope 95% CI: 1.0105 to 1.0294; Y-Intercept 95% CI: -4.1542 to 3.9916 |
| Matrix Comparison (Serum vs. Heparin Plasma) | Favorable regression analysis indicating acceptability | y = 0.9825x + 1.3632; Slope 95% CI: 0.9711 to 0.9939; Y-Intercept 95% CI: -2.8804 to 5.6067 |
Study Details for Demonstrating Acceptance Criteria:
1. Sample Size Used for the Test Set and Data Provenance:
- Precision:
- 6 samples (3 controls, 3 human serum samples) for within-device precision (assayed in duplicate twice a day for 20 days).
- 50 patient samples (ranging from 5.7 - 884.7 ng/mL) for between-lot precision (tested in duplicate with 3 different lots of reagent).
- Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective).
- Linearity / Analytical Range:
- 11 test concentrations prepared from analyte-spiked normal human serum samples diluted with analyte-depleted normal human serum.
- Each sample run 4 times.
- Data provenance not explicitly stated.
- Detection Limits (LoB, LoD, LoQ):
- LoB: 60 replicates of blank (analyte depleted human serum).
- LoD: 6 samples diluted to concentrations from LoB to 4xLoB (1.05 - 6.16 ng/mL).
- LoQ: 10 samples diluted to concentrations ranging from 1.0 to 10.0 ng/mL.
- Data provenance not explicitly stated.
- Analytical Specificity (Endogenous Interference):
- Two serum samples containing ferritin at ~82 ng/mL and ~445 ng/mL.
- Data provenance not explicitly stated.
- Analytical Specificity (Antigen Excess / Prozone):
- A set of 9 concentrations made by diluting analyte-spiked normal human serum (~80,000 ng/mL).
- Data provenance not explicitly stated.
- Method Comparison:
- 54 unaltered human serum samples (ferritin concentrations ranging from 5.9 to 994.4 ng/mL).
- Data provenance not explicitly stated.
- Matrix Comparison (Serum vs. EDTA Plasma):
- 65 matched serum and EDTA plasma patient samples (one sample spiked to extend range).
- Data provenance not explicitly stated.
- Matrix Comparison (Serum vs. Heparin Plasma):
- 59 matched serum and heparin plasma patient samples (14 samples spiked to extend range).
- Data provenance not explicitly stated.
2. Number of Experts and Qualifications for Ground Truth:
- Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of a biomarker. The "ground truth" for the performance studies is based on the inherent analytical properties of the samples themselves and comparison to a referenced standard or predicate device, rather than expert interpretation of images or clinical cases.
3. Adjudication Method for the Test Set:
- Not applicable. As an IVD assay, the performance is assessed through quantitative measurements and statistical analysis against predefined analytical criteria and/or predicate device results. There is no human adjudication process involved in establishing the "ground truth" for these analytical measurements.
4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. This is an in vitro diagnostic device for quantitative biomarker measurement. MRMC studies are typically used for imaging or diagnostic devices that involve human interpretation.
5. Standalone (Algorithm Only) Performance:
- Yes, implicitly. All described performance characteristics (precision, linearity, detection limits, analytical specificity, method comparison, matrix comparison) reflect the standalone performance of the K-ASSAY® Ferritin (2nd Gen.) assay on the Beckman/Olympus AU680 analyzer, without direct "human-in-the-loop" interaction for interpreting the results in these analytical performance studies. The output is a quantitative value, not an interpretation requiring a human reader.
6. Type of Ground Truth Used:
- Referenced Standards and Analytical Measurements:
- For Traceability, the ground truth for calibrator values is established against the WHO 2nd International Ferritin Standard, lot 80/578.
- For Precision, Linearity, and Detection Limits, the ground truth is based on the actual measured concentrations of analytes in well-characterized samples (e.g., controls, diluted samples, blank samples) and the statistical models used to derive these parameters according to CLSI guidelines.
- For Analytical Specificity, the ground truth for interference studies is the known concentration of the interferent added to samples and the observed effect on ferritin measurement.
- For Method Comparison, the ground truth is the result obtained from the predicate device (K-ASSAY® Ferritin (2) from K050944).
- For Matrix Comparison, the ground truth for serum, EDTA plasma, and heparin plasma is the measured ferritin concentration in matched samples.
7. Sample Size for the Training Set:
- Not explicitly stated/Not applicable in the conventional sense. This is a chemical/immunological assay, not a machine learning or AI-based device that would typically have a "training set" for an algorithm. The development of reagents and optimization of the assay protocol would involve numerous experiments and adjustments, but these are not referred to as statistical "training sets" in this context.
8. How the Ground Truth for the Training Set Was Established:
- Not applicable. As explained above, this device does not utilize a training set in the machine learning sense. The assay principle is based on immunoturbidimetry, where the signal generated directly correlates with the ferritin concentration, using a calibration curve established with known calibrator concentrations traceable to an international standard.
{0}------------------------------------------------
510(k) SUMMARY
- A. 510(k) Number: K121232
- B. Purpose for Submission: New Device
- C. Measurand: Ferritin
- D. Type of Test: Quantitative, immuno-turbidimetric
E. Applicant: Kamiya Biomedical Company
- F. Proprietary and Established Names: K-ASSAY® Ferritin (2nd Gen.) K-ASSAY® Ferritin Calibrator (2nd Gen.)
G. Regulatory Information:
-
- Regulation section: 21 CFR §866.5340 Ferritin immunological test system 21 CFR $862.1150 Calibrator
-
- Classification: Class II
-
- Product code: DBF: Ferritin, antigen, antiserum, control JIT: Calibrator, secondary
-
- Panel: Immunology (82) Clinical Chemistry (75)
H. Intended Use:
-
- Intended use(s):
K-ASSAY® Ferritin (2nd Gen.)
- Intended use(s):
The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements
{1}------------------------------------------------
of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.
K-ASSAY® Ferritin Calibrator (2nd Gen.)
The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.
-
- Indication(s) for use: Same as Intended Use.
-
- Special conditions for use statement(s): Prescription use only.
-
- Special instrument requirements: Beckman/Olympus AU680, K961274.
I. Device Description:
The K-ASSAY® Ferritin (2nd Gen.) assay is a latex enhanced immuno-turbidimetric assay for the quantitative in vitro determination of ferritin levels in serum and plasma (EDTA and heparin) samples.
The K-ASSAY® Ferritin (2nd Gen.) consists of two reagents. Reagent 1 contains HEPES buffer solution (50 mmol/L) and Reagent 2 contains HEPES buffer solution (50 mmol/L) and a solution of latex suspension with mouse monoclonal anti-human ferritin antibodies. Both reagents also contain less than 0:01 w/v% of sodium azide as a preservative.
| Reagent 1: | Reagent 2: |
|---|---|
| 50 mM HEPES | Latex particles sensitized with mouse |
| <0.01 w/v% Sodium Azide | monoclonal anti-human ferritin antibody |
| pH 7.4 ± 0.2 | 50 mM HEPES |
| <0.01 w/v% Sodium Azide | |
| pH 7.4 ± 0.1 |
The K-ASSAY® Ferritin Calibrators (2nd Gen.) are liquid stable products consisting of a human serum matrix and known quantities of human ferritin at 6 levels ranging from 0 -1,000 ng/mL (0, 25, 250, 500, 750, 1,000 ng/mL). The calibrators also contain less than 0.1 w/v% of sodium azide as a preservative.
J. Substantial Equivalence Information:
-
- Predicate device name(s) and predicate K number(s): K-ASSAY® Ferritin (2) and Ferritin Calibrator set (K050944)
-
- Comparison with predicate
Ferritin Reagent
{2}------------------------------------------------
| SIMILARITIES | |||
|---|---|---|---|
| a seltem and a | Device Device Care | Predicate | |
| Intended Use / | For the quantitative determination of ferritin (an | Same | |
| Indications for | iron-storing protein) in human serum and plasma by | ||
| Use | immunoturbidimetric assay. Measurements of | ||
| ferritin aid in the diagnosis of diseases affecting iron | |||
| overload and iron deficiency anemia. FOR IN | |||
| VITRO DIAGNOSTIC USE. | |||
| Measurement | Quantitative | Same | |
| Assay | Latex-enhanced immuno-turbidimetry | Same | |
| Principle | |||
| Sample Type | Serum, EDTA and heparin plasma | Same | |
| Format | Liquid | Same | |
| Uses | Yes | Same | |
| Calibration To | |||
| Determine | |||
| Ferritin Levels |
Note predicate reagent, originally registered as K-ASSAY® Ferritin (2) under K050944, is currently sold without the "(2)" as the older Ferritin was discontinued in 2007.
: 上一
| DIFFERENCES | ||
|---|---|---|
| Item | Device | Predicate |
| Reagents | Reaction buffer and latex particles coated with mouse anti-human ferritin monoclonal antibodies | Reaction buffer and latex particles coated with rabbit anti-human ferritin antibodies |
| Assay Range | 5 - 1,000 ng/mL | 2 - 1,000 ng/mL |
| Calibration | Six-point calibration curve(0, 25, 250, 500, 750, 1000 ng/mL) | Five-point calibration curve(0, 100, 200, 500, 1000 ng/mL) |
| Instrument | Beckman/Olympus AU680 | Roche/Hitachi 917 analyzer. |
| ExpectedValues(Serum) | Female: 10 - 200 ng/mLMale: 30 - 300 ng/mL(from the literature) | Female: 2 - 110 ng/mLMale: 7 - 253 ng/mL |
Calibrators
| SIMILARITIES | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use /Indications forUse | For calibration of the K-ASSAY®Ferritin (2nd Gen.) assay. FOR INVITRO DIAGNOSTIC USE. | Same |
| Matrix | Human Serum | Same |
| Analyte | Human Ferritin | Same |
{3}------------------------------------------------
| Item | Device | Predicate |
|---|---|---|
| Traceability /Standardization | WHO 2nd International FerritinStandard, lot 80/578 | WHO 1st International FerritinStandard, lot 80/602 |
| Levels | 6 | 4 + 1 (Saline Used for 0 ng/mLbut not Included) |
K. Standard/Guidance Document Referenced (if applicable):
-
- CLSI EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition, 2004.
-
- CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline, 2003.
-
- CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline, 2004.
-
- CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline -Second Edition, 2005.
-
- CLSI EP09-A2-IR: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition (Interim Revision), 2010.
L. Test Principle:
Human serum or plasma is mixed with a suspension of latex particles coated with purified mouse anti-human ferritin monoclonal antibodies. The resulting immune complexes are measured by turbidimetry. The signal generated is correlated with the concentration of ferritin in the sample. By interpolation on a calibration curve prepared from calibrations of known concentrations, the concentration of ferritin in the sample is calculated. The K-ASSAY® Ferritin (2nd Gen.) assay is analyzed using Beckman/Olympus AU680 clinical chemistry analyzer.
M. Performance Characteristics (if/when applicable):
-
- Analytical performance:
- Precision / Reproducibility: a.
Tests were performed according to the CLSI EP05-A2 guideline on 3 levels of controls and 3 levels of human serum samples, assayed in duplicate twice a day, for 20 days. The results are summarized in the table below:
| WANTED COLLECTION COLLECTION COLLECTION COLLECTION CONTINUES CONTINUES CONTINUES CONTINUES CONTENTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTERS CONTEN | THE CONSULTION CONSULTIONAL THE COLLECTION COLLEGIONAL CONSULTER PRODUCTION COLLECTION COLLECTION CONSULTERS OF THE CONSULTER OF THE CONSULTER OF THE CONSULTER OF THE CONSULT Between Between- Between Between | Between | ||
|---|---|---|---|---|
| · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · | also has be has be a be a first and the company ofa from the first and the first and the Research and and and the first the first for the first forSeptember 1992 (1992) 1991 (1997) 1991 (1997) 1999) 1999 (1999) S.D. S.D. CV% S.D. CV% S.D. (вестьементерначен рассия въ въвание света. | a har ku hand sa ku hay hay hay hafi fi ghigh gu mar may may na mana mana mana marka marka marka marka hama marka hama marka hama marka marka marka marka marka marka marka ma.CV% B. |
{4}------------------------------------------------
| Sample 1 | 58.140 | 0.792 | 1.362 | 0.709 | 1.219 | 0.141 | 0.243 | 1.072 | 1.844 |
|---|---|---|---|---|---|---|---|---|---|
| Sample 2 | 95.801 | 0.821 | 0.857 | 0.307 | 0.321 | 0.342 | 0.357 | 0.941 | 0.982 |
| Sample 3 | 979.193 | 3.341 | 0.341 | 5.188 | 0.530 | 5.242 | 0.535 | 8.097 | 0.827 |
| Sample 4 | 10.375 | 0.463 | 4.461 | 0.112 | 1.083 | 0.246 | 2.375 | 0.536 | 5.169 |
| Sample 5 | 22.378 | 0.535 | 2.390 | 0.411 | 1.838 | 0.166 | 0.744 | 0.695 | 3.105 |
| Sample 6 | 254.020 | 1.866 | 0.735 | 1.668 | 0.657 | 2.035 | 0.801 | 3.226 | 1.270 |
50 patient samples ranging from 5.7 - 884.7 ng/mL were tested in duplicate with 3 different lots of reagent. For each sample the mean and the standard deviation for the between-lot component of variance was calculated.
The 50 samples were divided into 4 groups of sizes 12, 13, 12, and 13 samples based on mean values; average CV%'s for the between-lot component for each group were calculated with the following results.
| Group | Range of Means Within Group | Average CV% |
|---|---|---|
| 1 | 5.7 - 28.0 ng/mL | 0.99 % |
| 2 | 37.3 - 82.0 ng/mL | 0.37 % |
| 3 | 95.7 - 187.3 ng/mL | 0.39 % |
| 4 | 187.5 - 884.7 ng/mL | 0.42 % |
The CV% for the between-lot precision was less than 1%.
- Linearity / assay analytical range: b.
Tests were performed according to the CLSI EP06-A guideline on diluted samples. Analyte spiked normal human serum samples were diluted with analyte depleted normal human serum to prepare 11 test concentrations to evaluate total range linearity. Testing was done using 1 reagent lot and all samples were run 4 times.
Calculations were performed according to CLSI EP06-A. The observed concentration (y axis) was compared to the expected concentration (x axis). Linear regression with 95% confidence intervals is below.
| Parameter | Estimate | 95% CI |
|---|---|---|
| Slope | 0.9999 | 0.9976 to 1.0022 |
| Intercept | 0.1249 | -0.9049 to 1.1546 |
Nonlinearity was assessed based on CLSI EP06-A guidelines by comparison to a pre-defined goal of 10% deviation. The K-ASSAY® Ferritin (2nd Gen.) assay was demonstrated to be linear throughout the claimed measuring range of 5 - 1,000 ng/mL.
{5}------------------------------------------------
- Traceability, Stability, Expected values (controls, calibrators, or methods): C.
- i. Traceability
The Ferritin values assigned to the calibrators are traceable to the WHO 2nd International Ferritin Standard, lot 80/578.
-
ii. Stability
The stability of the K-ASSAY® Ferritin (2nd Gen.) and calibrator were demonstrated with real-time stability studies. The unopened shelf life is 1 year for both the reagent and calibrators when stored at the recommended temperature of 2-8℃. The open-vial stability is 1 month for both the reagent and calibrator when stored at the recommended temperature of 2-8°C. An on-board stability study confirmed that the reagent is stable for at least 1 month on-board the Beckman/Olympus AU680 analyzer. -
d. Detection limit:
Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) for the K-ASSAY® Ferritin (2nd Gen.) assay were evaluated using the CLSI EP17-A guideline. Studies were performed on the Beckman/Olympus AU680 analyzer with the following results:
| Detection Limits: | |||||
|---|---|---|---|---|---|
| K-ASSAY® Ferritin (2nd Gen.) on Beckman/Olympus AU680 | |||||
| Limit | Protocol | Claimed Value | |||
| LoB | 60 replicates of blank (analyte depleted humanserum) were tested in twelve runs per day for 5days. | 1.039 ng/mL | |||
| LoD | 6 samples diluted to concentrations in the rangefrom LoB to 4xLoB (1.05 - 6.16 ng/mL) weretested in 4 runs per day over 5 days. | 1.825 ng/mL | |||
| LoQ | 10 samples were diluted to concentrationsranging from 1.0 to 10.0 ng/mL and tested in 8runs per day over 5 days.Acceptable bias: ≤ 2%Acceptable imprecision: %CV≤ 10% | 5.0 ng/mL |
- Analytical specificity: e.
- Endogenous Interference: . ...
Studies were performed according to CLSI EP07-A2. Two serum samples containing ferritin at concentrations of approximately 82 ng/mL and 445 ng/mL were evaluated with the K-ASSAY® Ferritin (2nd Gen.) assay on the Beckman/Olympus AU680 analyzer for the effect of interferences. The following substances demonstrated no significant interference based on acceptance criteria: ± 10% deviation of the control value:
{6}------------------------------------------------
| Substance | No Interference up to |
|---|---|
| Bilirubin C | 20 mg/dL |
| Bilirubin F | 20 mg/dL |
| Hemoglobin | 500 mg/dL |
| Rheumatoid Factor | 1,000 IU/mL |
| Sodium Citrate | 1,000 mg/dL |
| Sodium EDTA | 500 mg/dL |
| Sodium Fluoride | 1,000 mg/dL |
| Sodium Heparin | 20 mg/dL |
| Turbidity | 2,000 FTU |
-
ii. Antigen Excess (Prozone):
Analyte spiked normal human serum (~80,000 ng/mL) was diluted to obtain a set of 9 concentrations. Up to 80,000 ng/mL, the measured value does not decrease to less than 1,000 ng/mL (the upper limit of assay linearity) -
f. Assay cut-off:
See expected values/reference range. -
- Comparison studies:
- Method comparison with predicate device: ા.
A total of 54 unaltered human serum samples containing ferritin concentrations ranging from 5.9 to 994.4 ng/mL were tested with the K-ASSAY® Ferritin (2nd Gen.) assay and the predicate device on the Beckman/Olympus AU680 analyzer according to CLSI E0P9-A2-IR guidelines. Regression analysis resulted in the following data:
| Regression Equation |
|---|
| $y = 1.0057x + 0.0968$ |
| Slope 95% Confidence Interval: 1.0022 to 1.0092 |
| Y-Intercept 95% Confidence Interval: -1.1690 to 1.3625 |
- Matrix comparison: b.
- Serum Vs. EDTA Plasma i.
65 matched serum and EDTA plasma patient samples were collected. One sample was spiked to help cover the measuring range. Regression analysis results in the following data:
| Regression Equation |
|---|
| $y = 1.0199x - 0.0813$ |
| Slope 95% Confidence Interval: 1.0105 to 1.0294 |
| Y-Intercept 95% Confidence Interval: -4.1542 to 3.9916 |
- ii. Serum Vs. Heparin Plasma
{7}------------------------------------------------
59 matched serum and heparin plasma patient samples were collected. To cover the entire measuring range, 14 samples were spiked. Regression analysis results in the following data:
Regression Equation y = 0.9825x + 1.3632 Slope 95% Confidence Interval: 0.9711 to 0.9939 Y-Intercept 95% Confidence Interval: -2.8804 to 5.6067
Serum, EDTA plasma, and heparin plasma are shown to be acceptable assay specimens.
-
- Clinical studies:
- Clinical Sensitivity: a. Not applicable.
- b. Clinical specificity: Not applicable.
-
- Clinical cut-off See Expected values/Reference range.
-
- Expected values / Reference range: The package inert provides the reference range from literature: Female: 10 - 200 ng/mL (serum) Male: 30 - 300 ng/mL (serum)
Each laboratory is recommended to establish its own reference range.
{8}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized emblem, which is a modern, abstract representation of a human figure. The emblem is composed of three curved lines that suggest the form of a person in motion or reaching upwards.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Kamiva Biochemical Company C/O Mr. Shawn Kaplan 12779 Gateway Drive Seattle, Washington, 98168
SY 2 4 2012
Re: K121232
Trade/Device Name: K-Assay® Ferritin Reagent, K-Assay® Ferritin Calibrator Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: Class II Product Code: DBF, JIT Dated: April 19, 2012 Received: April 24, 2012
Dear Mr. Kaplan:
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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket witification. The FDA finding of substantial equivalence of your device to a legally marketed
{9}------------------------------------------------
Page 2 – Mr. Shawn Kaplan
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
Maria M. Chan, Ph. D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
KAMIYA BIOMEDICAL COMPANY
12779 Gateway Drive, Seattle, WA 98168 USA
Tel: 206.575.8068 Fax: 206.575.8094
INDICATIONS FOR USE STATEMENT
K121232 510(k) Number (if known):
Device Name: Ferritin Assay
Indications For Use:
The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY ® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. FOR IN VITRO DIAGNOSTIC USE.
Prescription Use V (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 Devices (OIVD)
hm
Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121232
Page 1 of
KAMIYA BIOMEDICAL COMPANY
K-ASSAY® Ferritin (2nd Gen.) Assay 510(k) Page 4
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).