(149 days)
Tosoh AIA-PACK RBC FOLATE is designed for in vitro diagnostic use only for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood (Heparin or EDTA) samples on TOSOH AIA system analyzer. Measurement of RBC Folate is used in the diagnosis and treatment of anemia.
The Tosoh AIA-PACK RBC FOLATE is a competitive enzyme immunoassay which, after sample hemolysis and sample pretreatment, is performed entirely within the AIA-PACK. First, sample hemolysis is performed to achieve complete hemolysis of erythrocytes and deconjugation to monoglutamate in the whole blood sample using sample hemolyzing reagents (containing ascorbic acid). After sample hemolysis, sample pretreatment is performed to release folate from endogenous binding proteins in the hemolysate sample using sample pretreatment reagents (containing sodium hydroxide and dithiothreitol). Folate present in the pretreated test sample competes with enzyme-labeled folate for a limited number of binding sites on a fluorescein labeled bovine folate binding protein which then binds to anti-FITC (fluorescein isothiocyanate) antibody immobilized on magnetic beads. The beads are washed to remove the unbound enzyme-labeled folate and are then incubated with a fluorogenic substrate, 4-methylumbelifery| phosphate (4MUP). The amount of enzyme labeled folate that binds to the beads is inversely proportional to the folate concentration in the test sample. A standard curve using a range of known standard concentrations is constructed and unknown folate concentrations are calculated using this curve.
The Tosoh AIA-PACK RBC FOLATE is a device designed for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood samples, used in the diagnosis and treatment of anemia. The device's performance was evaluated through various studies to demonstrate substantial equivalence to a predicate device (Bayer K010050, ADVIA Centaur and ACS: 180 Folate Immunoassay).
The document provides performance data for several criteria: Recovery, Dilution, Linearity, Precision, Correlation, Specificity, and Limit of Detection (LoD)/Limit of Quantitation (LoQ). Acceptance criteria are not explicitly stated as distinct numerical targets but are implied by the reported performance and the overall conclusion of substantial equivalence based on established CLSI protocols.
Here's a breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied by CLSI Protocols and Performance) | Reported Device Performance |
|---|---|---|---|
| Recovery | Percent Recovery | Generally 90-110% (standard for spiked recovery studies) | Ranged from 94.2% to 102.7% (demonstrated good recovery) |
| Dilution | Percent Recovery (after serial dilution) | Generally 90-110% (standard for dilution linearity studies) | Ranged from 100.0% to 114.7% (demonstrated good linearity upon dilution) |
| Linearity | Linear range with ±10% difference | Linear from 0.5 to 40.0 ng/mL, within ±10% | Demonstrated linearity from 0.5 to 40.0 ng/mL, within ±10% difference. The claimed linearity was 0.62 to 24.0 ng/mL. |
| Precision | Within-run CV (%) | Typically < 10% for low concentrations, < 5% for higher. | Control 1 (low): 5.9%, Control 2: 3.4%, Control 3 (high): 2.2%, Sample A3: 2.2% |
| Total CV (%) | Typically < 15% for low concentrations, < 10% for higher. | Control 1 (low): 8.2%, Control 2: 4.6%, Control 3 (high): 3.3%, Sample A3: 4.2% | |
| Correlation (EDTA vs. Heparin) | Correlation Coefficient (r) | Typically > 0.95 for strong correlation | 0.99 |
| Slope (Deming Regression) | Close to 1 (e.g., 0.9-1.1) | 0.959 (0.922 to 0.996) | |
| Y-intercept (Deming Regression) | Close to 0 | - 3.890 (-13.512 to 5.732) | |
| Correlation (vs. Alternate Method) | Correlation Coefficient (r) | Typically > 0.90 for good correlation | 0.87 (Deming Regression), 0.86 (Linear Regression with hematocrit correction) |
| Slope (Deming Regression) | Close to 1 (e.g., 0.9-1.1) | 1.06 (0.950 to 1.168), 1.00 (0.897 to 1.107 with hematocrit correction) | |
| Y-intercept (Deming Regression) | Close to 0 | -19.554 (-44.640 to 5.532), -26.60 (with hematocrit correction) | |
| Specificity | Cross-reactivity (%) for common interferences | Low percentage (e.g., < 1%) | Amethopterin: 0.66%, Leucovorin: 0.34% |
| LoD/LoQ | Limit of Detection (LoD) | As determined by CLSI EP17-A protocols | 0.43 ng folate/mL |
| Limit of Quantitation (LoQ) at 20% CV | As determined by CLSI EP17-A protocols | 0.62 ng folate/mL |
2. Sample Size and Data Provenance for Test Set:
- Recovery Study: 3 whole blood (EDTA) samples, each spiked at 3 different levels.
- Dilution Study: 3 whole blood (EDTA) samples.
- Precision Study: 3 commercially available controls and 1 whole blood (EDTA) control.
- Correlation (EDTA vs. Heparin) Study: 50 patient samples.
- Correlation (vs. Alternate Method) Study: 101 patient specimens.
- LoD/LoQ Study: Blank sample with 60 replicates; 7 low-level samples with 10 replicates each.
The document does not explicitly state the country of origin for the patient samples used in the correlation studies, nor does it specify whether the data was retrospective or prospective. Given the nature of an in vitro diagnostic device regulatory submission, it is typically presumed to be clinical samples, often from a diverse patient population, collected prospectively or obtained retrospectively under controlled conditions for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth:
The studies described are primarily analytical performance studies for an in vitro diagnostic (IVD) device, not directly involving human interpretation of results in a diagnostic setting (i.e., not an image-based AI device relying on expert radiologists for ground truth). Therefore, the concept of "experts establishing ground truth" in the manner requested is not applicable here.
- Ground truth for these studies is established through reference methods and known concentrations of analytes in controls and spiked samples, measured by established laboratory practices and instrumentation.
- The "experts" involved would be qualified laboratory personnel (e.g., clinical laboratory scientists, chemists) conducting the assays and analyzing data according to standard operating procedures and CLSI guidelines. Their qualifications are inherent in their ability to perform and interpret such analytical studies.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the ground truth is based on quantitative analytical measurements, not on subjective expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., reading medical images) where the AI aids human performance. The AIA-PACK RBC FOLATE is an automated analytical assay, and its performance is evaluated directly against known analytical values or comparative analytical methods, not human readers.
6. Standalone (Algorithm Only) Performance:
Yes, the studies effectively demonstrate standalone performance. The "device" in this context is the AIA-PACK RBC FOLATE assay run on a Tosoh AIA system analyzer. All the reported performance data (Recovery, Dilution, Linearity, Precision, LoD/LoQ, Specificity) demonstrate the intrinsic analytical capabilities of the assay without direct human intervention in the interpretive phase. Human operators perform the sample preparation and run the analyzer, but the measurement and calculation of folate concentration is algorithmic within the system. The correlation studies compare this standalone analytical result to other analytical methods or sample types.
7. Type of Ground Truth Used:
The ground truth used for these studies includes:
- Known concentrations: For recovery and linearity studies, samples were spiked with known amounts of folate to determine expected values. Commercial controls with established target values were also used for precision.
- Reference methods/Comparison methods: For correlation studies, the device's measurements were compared against an "alternate method" (likely another legally marketed Folate immunoassay) and against each other (EDTA vs. Heparin whole blood) to establish agreement.
- Analytical measurement techniques: The core ground truth for an IVD kit is its ability to accurately and precisely measure the analyte (RBC Folate) based on its chemical and immunological principles.
8. Sample Size for the Training Set:
The document does not explicitly mention a "training set" in the context of machine learning. For an immunoassay, the "training" aspect refers to the development and optimization of the assay reagents, protocols, and standard curve generation. This typically involves extensive R&D work using numerous samples and iterations to establish the optimal conditions and calibration. The calibration process for this device uses a 6-point calibration curve. The specific sample size for developing these foundational elements is not detailed but would precede the formal validation studies presented.
9. How the Ground Truth for the Training Set was Established:
As mentioned, "ground truth for a training set" is not directly applicable in the AI/ML sense for a traditional immunoassay. For an immunoassay, the "ground truth" for developing the assay and its calibration would be established through:
- Highly purified folate standards: Used to create the calibration curve and to spike samples for recovery and linearity.
- Reference materials: Certified reference materials or well-characterized patient samples with established folate concentrations from orthogonal or highly accurate methods.
- Methodology optimization: Iterative testing and adjustment of reagent concentrations, incubation times, antibody affinities, and detection limits to achieve the desired analytical performance.
The calibration curve itself (6-point calibration) serves as the "learned" relationship between signal and concentration, established using known folate standards.
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Rec'd
9/25/09
K091332
OCT - 2 2009
Section 5
: 上一篇:
510(K) Summary
.
RBC FOLATE
Section 5
1 of 8
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510k Summary
Tosoh AIA-PACK RBC FOLATE
Tosoh Bioscience, Inc. 3600 Gantz Road Grove City, OH 43123
April 15, 2009
Date:
Submitter:
Contact Person:
Judith K. Ogden Director, New Business and Technical Development Tosoh Bioscience, Inc. 6000 Shoreline Court, Suite 101, South San Francisco, CA 94080 Phone: (650) 636-8112
Device Name:
Classification Name:
Predicate Device:
AIA-PACK RBC FOLATE
Class II CGN 21 CFR 862.1295 Folic Acid Test System
K010050, ADVIA Centaur and ACS: 180 Folate Immunoassay, Manufactured by Bayer Diagnostics Corp.
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510(k) Summary
AIA-PACK RBC FOLATE
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Device Description:
The Tosoh AIA-PACK RBC FOLATE is a competitive enzyme immunoassay which, after sample hemolysis and sample pretreatment, is performed entirely within the AIA-PACK. First, sample hemolysis is performed to achieve complete hemolysis of erythrocytes and deconjugation to monoglutamate in the whole blood sample using sample hemolyzing reagents (containing ascorbic acid). After sample hemolysis, sample pretreatment is performed to release folate from endogenous binding proteins in the hemolysate sample using sample pretreatment reagents (containing sodium hydroxide and dithiothreitol).
Folate present in the pretreated test sample competes with enzyme-labeled folate for a limited number of binding sites on a fluorescein labeled bovine folate binding protein which then binds to anti-FITC (fluorescein isothiocyanate) antibody immobilized on magnetic beads. The beads are washed to remove the unbound enzyme-labeled folate and are then incubated with a fluorogenic substrate, 4-methylumbelifery| phosphate (4MUP). The amount of enzyme labeled folate that binds to the beads is inversely proportional to the folate concentration in the test sample. A standard curve using a range of known standard concentrations is constructed and unknown folate concentrations are calculated using this curve.
The following products are required to use the Tosoh AIA-PACK RBC FOLATE. AIA-PACK RBC FOLATE Calibrator Set. AIA-PACK RBC FOLATE Sample Diluting Solution. AIA-PACK RBC FOLATE Pretreatment Set. AIA-PACK RBC FOLATE Hemolyzing Reagent Set.
Device Intended Use:
AIA-PACK RBC Folate is designed for in vitro diagnostic use only for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood (heparin or EDTA) samples on Tosoh AIA system analyzer. Measurement of RBC Folate is used in the diagnosis and treatment of anemia.
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Substantial Equivalence:
Baver ADVIA Centaur® Tosoh AIA-PACK RBC Specifications FOLATE FOL Lite Reagent K010050 In Vitro Diagnostic Use for the In Vitro Diagnostic Use Intended Use quantitative measurement of for the quantitative red blood cell folate (RBC determination of folate in FOLATE). Measurement of serum or red blood cells. RBC Folate is used in the diagnosis and treatment of anemia. Competitive enzyme Competitive Methodology immunoassay using immunoassay using fluorescence detection direct chemiluminescent technology Whole blood EDTA or heparin Whole blood EDTA or Sample Type heparin ADVIA Centaur Lite Assay Components AIA-PACK RBC FOLATE test reagent pack, DTT/ cups, pretreatment set, hemolyzing reagent set, Releasing Agent, FOL calibrator set, sample diluting Ascorbic acid/Ascorbic solution acid diluent, FOL diluent, FOL calibrator Purified avidin bonded Solid Phase Lyophilized magnetic beads coated with anti-FITC mouse to paramagnetic particles in buffer with monoclonal antibody and fluorescein labeled bovine human serum albumin folate binding protein and and preservatives preservatives Conjugate Alkaline phosphatase Acridinium ester Calibrators 6-point calibration 2-point calibration Assay Low 0.35 ng/mL (MDC) 0.62 ng Folate/mL (based on LOQ) 24 ng/mL Assay High 24 ng Folate/mL 7 Days Calibration Frequency 90 Davs 30 minutes 90 minutes Time to prepare hemolysate 40 Minutes 5 Minutes + 2.5 Minutes Incubation Specimen Vol (Hemolysate) 150 uL 160 ul Specimen Volume (Whole 50 ul 50 ul Blood) 3.4 – 10.3 ng folate/mL Reference Range 280-791 ng/mL 148 - 531 ng RBC folate/mL Hemolvzing Reagent-1 1 day after reconstitution 30 days after reconstitution (5mL) Stability Hemolyzing Reagent -2 (65 30 days after reconstitution Not applicable mL) Stability Hemolysate Stability 5 Hours 3 Hours
Comparison between Tosoh and Bayer -RBC Folate
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| Frozen – 60 days | Frozen - 90 days | |
|---|---|---|
| Hemolysate MultiplicationFactor | 22 | 21 |
| Calculation Of Final Results | Manual | Automatic |
| Corrected Value For RBCFolate In High SerumFolate Samples | Yes | Yes |
Recovery:
Recovery: Three whole blood (EDTA) samples were spiked with three different levels of RBC Folate and assayed before and after spiking.
| Sample | InitialValue(ngFolate/mL) | FolateAdded(ng/mL) | ExpectedValue(ngFolate/mL) | MeasuredValue (ngFolate/mL) | ExpectedValue(ng RBCfolate/mL) | MeasuredValue(ng RBCfolate/mL) | PercentRecovery(%) |
|---|---|---|---|---|---|---|---|
| SampleA1 | 4.9 | 5.1 | 10.0 | 10.2 | 487.0 | 500.1 | 102.7 |
| 4.9 | 10.1 | 15.0 | 15.2 | 735.0 | 744.4 | 101.3 | |
| 4.9 | 20.3 | 25.2 | 24.6 | 1230.9 | 1205.0 | 97.9 | |
| SampleB1 | 2.0 | 5.3 | 7.2 | 7.2 | 353.6 | 352.8 | 99.8 |
| 2.0 | 10.5 | 12.5 | 12.3 | 610.5 | 601.7 | 98.6 | |
| 2.0 | 21.0 | 23.0 | 22.4 | 1124.2 | 1095.4 | 97.4 | |
| SampleC1 | 5.4 | 5.3 | 10.7 | 10.7 | 520.7 | 521.6 | 100.2 |
| 5.4 | 10.5 | 15.9 | 15.2 | 777.6 | 743.0 | 95.5 | |
| 5.4 | 21.0 | 26.4 | 24.9 | 1291.4 | 1216.1 | 94.2 |
Dilution: Three whole blood (EDTA) samples containing high concentrations of folate were serially diluted with AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTION and assayed.
| Sample | DilutionFactor | ExpectedValue (ngFolate/mL) | MeasuredValue(ngFolate/mL) | ExpectedValue(ng RBCfolate/mL) | MeasuredValue(ng RBCfolate/mL) | PercentRecovery(%) |
|---|---|---|---|---|---|---|
| Sample A2Hematocrit:45.0% | None | 32.4 | 32.4 | 1583.7 | 1583.7 | 100.0 |
| 7.5/10 | 24.3 | 25.4 | 1187.7 | 1242.9 | 104.6 | |
| 5.0/10 | 16.2 | 17.3 | 791.8 | 844.2 | 106.6 | |
| 2.5/10 | 8.1 | 8.6 | 395.9 | 419.1 | 105.9 | |
| 1.0/10 | 3.2 | 3.2 | 158.4 | 158.4 | 100.0 | |
| Sample B2Hematocrit:45.0% | None | 22.5 | 22.5 | 1098.8 | 1098.8 | 100.0 |
| 7.5/10 | 16.9 | 17.2 | 824.1 | 840.2 | 102.0 | |
| 5.0/10 | 11.2 | 11.6 | 549.4 | 566.4 | 103.1 | |
| 2.5/10 | 5.6 | 6.4 | 274.7 | 315.2 | 114.7 | |
| 1.0/10 | 2.2 | 2.5 | 109.9 | 124.3 | 113.1 | |
| Sample C2 | None | 7.7 | 9.1 | 444.5 | 444.5 | 100.0 |
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| Hematocrit:37.9% | 7.5/10 | 5.7 | 7.1 | 333.4 | 348.0 | 104.4 |
|---|---|---|---|---|---|---|
| 5.0/10 | 2.1 | 4.9 | 222.3 | 238.3 | 107.2 | |
| 2.5/10 | 0.5 | 2.6 | 111.1 | 125.1 | 112.5 | |
| 1.0/10 | 0.1 | 0.9 | 44.5 | 45.8 | 103.0 |
Linearity: The linearity testing for AIA-PACK RBC FOLATE was based on CLSI Protocol EP6-A. The linearity was measured on the AIA-1800, and was demonstrated to be linear from 0.5 to 40.0 ng /mL, within ±10% difference in this interval. The claimed linearity was 0.62 to 24.0 ng /mL based on discussion with the U.S. FDA.
Precision:
The precision protocol for AIA-PACK RBC FOLATE followed CLSI EP5-A2. Precision studies were conducted at one site over a period of 92 days. An AIA-1800 was used to collect the data. All data was collected on one calibration curve by one operator. The lot number of the reagent pack was G611660 and the lot number of the calibrator set was 6075 C1-C6.
2a) Within run precision was determined using three commercially available controls and one whole blood control (EDTA) in a total of 20 runs. Within each run, one set of duplicates per control was assayed. The mean of each duplicate was used to obtain the pooled standard deviation (SD), which was then used to calculate the coefficient of variation (CV).
| Sample | Hematocrit(%) | Mean(ngFolate/mL) | SD(ngFolate/mL) | Mean(ng RBC folate/mL) | CV (%) |
|---|---|---|---|---|---|
| Control 1 | 45.0 | 1.90 | 0.112 | 92.8 | 5.9 |
| Control 2 | 45.0 | 6.92 | 0.232 | 338.2 | 3.4 |
| Control 3 | 45.0 | 23.33 | 0.509 | 1140.5 | 2.2 |
| Sample A3 | 45.0 | 6.14 | 0.133 | 300.4 | 2.2 |
2b) Total precision was determined by the duplicate assay of three commercially available controls and one whole blood (EDTA) control in 20 separate runs. The means of each run were used to calculate the standard deviation (SD) and coefficient of variation (CV).
| Sample | Hematocrit(%) | Mean(ng/mL) | SD(ng Folate/mL) | Mean(ng RBC folate/mL) | CV (%) |
|---|---|---|---|---|---|
| Control 1 | 45.0 | 1.90 | 0.155 | 92.8 | 8.2 |
| Control 2 | 45.0 | 6.92 | 0.317 | 338.2 | 4.6 |
| Control 3 | 45.0 | 23.33 | 0.761 | 1140.5 | 3.3 |
| Sample A3 | 45.0 | 6.14 | 0.256 | 300.4 | 4.2 |
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Correlation:
The correlation between whole blood (EDTA) and whole blood (heparin) was performed using 50 patient samples.
| After Correction for dilution factor | After correction for dilution andhematocrit | |||
|---|---|---|---|---|
| Demingregression | LinearRegression | DemingRegression | LinearRegression | |
| Slope | 0.959(0.922 to 0.996) | 0.951 (0.914 to0.988) | 0.955 (0.917 to0.993) | 0.946 (0.908 to0.984) |
| y-Intercept | - 3.890 (-13.512to 5.732) | - 2.133 (-11.736to 7.469) | - 9.144 (-36.130to 17.842) | 4.068 (-30.996to 22.860) |
| Correlation Coefficient | 0.99 | 0.99 | ||
| Number of Samples (n) | 50 | 50 | ||
| Measurement Range | 34.90 to 523.37 ng folate/mL | 151.59 to 1404.65 ngRBC folate/mL |
The conclusion is that whole blood (heparin) specimens were found to be substantially equivalent in performance to whole blood (EDTA) specimens.
The correlation protocol for AIA-PACK RBC FOLATE followed CLSI Protocol EP9-A2. The correlation for AIA-PACK RBC FOLATE was determined based on guidance from CLSI Protocol EP9-A2. The correlation between AIA-PACK RBC FOLATE and an alternate method was carried out using 101patient specimens.
| After Correction for dilution factor | After correction for dilution andhematocrit | |||
|---|---|---|---|---|
| Demingregression | LinearRegression | DemingRegression | LinearRegression | |
| Slope | 1.06 (0.950 to1.168) | 0.91 (0.805 to1.015) | 1.00 (0.897 to1.107) | 0.86 (0.761 to0.964) |
| y-Intercept | -19.554 (-44.640to 5.532) | 12.22 (-11.909to 36.353) | -26.60 | 58.40 |
| Correlation Coefficient | 0.87 | 0.86 | ||
| Number of Samples (n) | 101 | 101 | ||
| Measurement Range | 49.06 - 491.04 ng folate/mL | 185 - 1333 ng RBC folate/mL |
Specificity: The following substances were tested for cross-reactivity. The crossreactivity (%) is the percent of the compound which will be identified as RBC Folate. If these compounds are present in the specimen at the same concentration as RBC Folate, the final result will be increased by the percentages shown.
| Compound | Concentration | Cross-reactivity (%) |
|---|---|---|
| Amethopterin | 2,518 ng/mL | 0.66 |
| Leucovorin | 5,231 ng/mL | 0.34 |
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Limit of Detection (LoD) and Limit of Quantitation (LoQ):
The limit of detection (LOD) and limit of quantitation (LOQ) for AIA-PACK RBC FOLATE was determined based on guidance from CLSI Protocol EP17-A. The blank sample was measured in 60 replicates. Seven low level samples were measured in 10 replicates each. The limit of detection for AIA-PACK RBC FOLATE was estimated to be 0.43 ng folate/mL. The limit of blank was 0.19 ngfolate/mL. The limit of quantitation was 0.62 ng folate/mL at 20% CV.
Standards:
| Number | FDARecognitionNumber | Revision | Title |
|---|---|---|---|
| C28-A2NCCLS | 7-81 | June 2000 | How to Define and Determine Reference Intervalsin the Clinical Laboratory; Approved Guideline -Second Edition |
| EP5-A2NCCLS | 7-110 | 8/20/04 | Evaluation of Precision Performance ofQuantitative Measurement Methods; ApprovedGuideline-Second Edition |
| EP6-ANCCLS | 7-193 | 4/1/03 | Evaluation of the Linearity of QuantitativeMeasurement Procedures; A Statistical Approach;Approved Guideline |
| EP9-A2NCCLS | 7-92 | 9/20/02 | Method Comparison and Bias Estimation UsingPatient Samples; Approved Guideline - SecondEdition |
| EP17-ANCCLS | 7 - 194 | 10/20/04 | Protocols for Determination of Limits of Detectionand Limits of Quantitation; Approved Guideline |
Conclusion:
The Tosoh Bioscience, Inc. AIA-PACK RBC FOLATE ASSAY is substantially equivalent to the Bayer K010050, ADVIA Centaur and ACS: 180 Folate Immunoassay for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood (heparin or EDTA) samples on Tosoh AIA system analyzer.
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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Tosoh BioScience, Inc. c/o Ms. Judith K. Ogden Director, New Business & Technical Development 6000 Shoreline Court, Suite 101 South San Francisco. CA 94080
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K091332
Trade Name: Tosoh AIA-Pack RBC Folate Regulation Number: 21 CFR $862,1295 Regulation Name: Folic Acid Test System. Regulatory Class: Class II Product Codes: CGN Dated: September 28, 2009 Received: September 29, 2009
OCT - 2 2009
Dear Ms. Ogden:
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 (OS) regulation (21 CFR Part 820).
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Page 2
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/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name:
Indication For Use:
091332
Tosoh AIA-PACK RBC FOLATE
Tosoh AIA-PACK RBC FOLATE is designed for in vitro diagnostic use only for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood (Heparin or EDTA) samples on TOSOH AIA system analyzer. Measurement of RBC Folate is used in the diagnosis and treatment of anemia.
Prescription Use V (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 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)
Division Sign Off
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.