(149 days)
K010050, ADVIA Centaur and ACS: 180 Folate Immunoassay
Not Found
No
The device description details a competitive enzyme immunoassay and standard curve calculation, which are traditional biochemical methods, not AI/ML. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
No.
The device is for in vitro diagnostic use, meaning it measures substances in samples taken from the body, rather than directly treating a condition within the body. Its output is used in the diagnosis and treatment of anemia, not as a treatment itself.
Yes
The device 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," and "Measurement of RBC Folate is used in the diagnosis and treatment of anemia." This directly indicates its role in diagnosing a medical condition.
No
The device description clearly outlines a competitive enzyme immunoassay involving reagents, magnetic beads, and a fluorogenic substrate, which are all physical components, not software. The device is an in vitro diagnostic assay kit used with a TOSOH AIA system analyzer, which is also hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "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... Measurement of RBC Folate is used in the diagnosis and treatment of anemia." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a laboratory test performed on a biological sample (whole blood) using reagents and an analyzer. This is characteristic of an in vitro diagnostic test.
- Intended User / Care Setting: The "Intended User / Care Setting" section also states "in vitro diagnostic use".
All these points confirm that the Tosoh AIA-PACK RBC FOLATE is intended for use outside of the body to diagnose or provide information for the treatment of a medical condition, which is the definition of an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
CGN
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-methylumbeliferyl 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Recovery: Three whole blood (EDTA) samples were spiked with three different levels of RBC Folate and assayed before and after spiking.
Percent recovery ranged from 94.2% to 102.7%.
Dilution: Three whole blood (EDTA) samples containing high concentrations of folate were serially diluted with AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTION and assayed.
Percent recovery ranged from 100.0% to 114.7%.
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.
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 using an AIA-1800.
Within run precision: Control 1 (Mean RBC folate 92.8 ng/mL) CV 5.9%; Control 2 (Mean RBC folate 338.2 ng/mL) CV 3.4%; Control 3 (Mean RBC folate 1140.5 ng/mL) CV 2.2%; Sample A3 (Mean RBC folate 300.4 ng/mL) CV 2.2%.
Total precision: Control 1 (Mean RBC folate 92.8 ng/mL) CV 8.2%; Control 2 (Mean RBC folate 338.2 ng/mL) CV 4.6%; Control 3 (Mean RBC folate 1140.5 ng/mL) CV 3.3%; Sample A3 (Mean RBC folate 300.4 ng/mL) CV 4.2%.
Correlation: The correlation between whole blood (EDTA) and whole blood (heparin) was performed using 50 patient samples.
Correlation Coefficient: 0.99 (both with and without correction for dilution and hematocrit).
Measurement Range: 34.90 to 523.37 ng folate/mL (after correction for dilution factor), 151.59 to 1404.65 ng RBC folate/mL (after correction for dilution and hematocrit).
Conclusion: whole blood (heparin) specimens were found to be substantially equivalent in performance to whole blood (EDTA) specimens.
Specificity: The cross-reactivity of Amethopterin (2,518 ng/mL) was 0.66% and Leucovorin (5,231 ng/mL) was 0.34%.
Limit of Detection (LoD) and Limit of Quantitation (LoQ): LoD was 0.43 ng folate/mL. LoQ was 0.62 ng folate/mL at 20% CV.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K010050, ADVIA Centaur and ACS: 180 Folate Immunoassay
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Rec'd
9/25/09
K091332
OCT - 2 2009
Section 5
: 上一篇:
510(K) Summary
.
RBC FOLATE
Section 5
1 of 8
. . .
1
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.
2
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.
3
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
4
| Frozen – 60 days | Frozen - 90 days | |
|---|---|---|
| Hemolysate Multiplication | ||
| Factor | 22 | 21 |
| Calculation Of Final Results | Manual | Automatic |
| Corrected Value For RBC | ||
| Folate In High Serum | ||
| Folate 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 | Initial
Value
(ng
Folate/mL) | Folate
Added
(ng/mL) | Expected
Value
(ng
Folate/mL) | Measured
Value (ng
Folate/mL) | Expected
Value
(ng RBC
folate/mL) | Measured
Value
(ng RBC
folate/mL) | Percent
Recovery
(%) |
|--------------|---------------------------------------|----------------------------|----------------------------------------|-------------------------------------|--------------------------------------------|--------------------------------------------|----------------------------|
| Sample
A1 | 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 |
| Sample
B1 | 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 |
| Sample
C1 | 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 | Dilution
Factor | Expected
Value (ng
Folate/mL) | Measured
Value
(ng
Folate/mL) | Expected
Value
(ng RBC
folate/mL) | Measured
Value
(ng RBC
folate/mL) | Percent
Recovery
(%) |
|-------------------------------|--------------------|-------------------------------------|----------------------------------------|--------------------------------------------|--------------------------------------------|----------------------------|
| Sample A2
Hematocrit: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 B2
Hematocrit: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 |
5
| 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
(ng
Folate/mL) | SD
(ng
Folate/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 |
6
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 and
hematocrit | |
|-------------------------|--------------------------------------|-------------------------------|-------------------------------------------------|------------------------------|
| | Deming
regression | Linear
Regression | Deming
Regression | Linear
Regression |
| Slope | 0.959
(0.922 to 0.996) | 0.951 (0.914 to
0.988) | 0.955 (0.917 to
0.993) | 0.946 (0.908 to
0.984) |
| y-Intercept | - 3.890 (-13.512
to 5.732) | - 2.133 (-11.736
to 7.469) | - 9.144 (-36.130
to 17.842) | 4.068 (-30.996
to 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 and
hematocrit | |
|-------------------------|--------------------------------------|------------------------------|-------------------------------------------------|--------------------------|
| | Deming
regression | Linear
Regression | Deming
Regression | Linear
Regression |
| Slope | 1.06 (0.950 to
1.168) | 0.91 (0.805 to
1.015) | 1.00 (0.897 to
1.107) | 0.86 (0.761 to
0.964) |
| y-Intercept | -19.554 (-44.640
to 5.532) | 12.22 (-11.909
to 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 |
7
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 | FDA
Recognition
Number | Revision | Title |
|-----------------|------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------|
| C28-A2
NCCLS | 7-81 | June 2000 | How to Define and Determine Reference Intervals
in the Clinical Laboratory; Approved Guideline -
Second Edition |
| EP5-A2
NCCLS | 7-110 | 8/20/04 | Evaluation of Precision Performance of
Quantitative Measurement Methods; Approved
Guideline-Second Edition |
| EP6-A
NCCLS | 7-193 | 4/1/03 | Evaluation of the Linearity of Quantitative
Measurement Procedures; A Statistical Approach;
Approved Guideline |
| EP9-A2
NCCLS | 7-92 | 9/20/02 | Method Comparison and Bias Estimation Using
Patient Samples; Approved Guideline - Second
Edition |
| EP17-A
NCCLS | 7 - 194 | 10/20/04 | Protocols for Determination of Limits of Detection
and 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.
8
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).
9
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
10
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