(205 days)
Not Found
No
The device description details a standard enzyme immunoassay method for measuring HbA1c. There is no mention of AI or ML in the device description, performance studies, or key metrics. The calculation of unknown concentrations is based on a standard curve, which is a traditional analytical method, not AI/ML.
No.
This device is an in vitro diagnostic (IVD) device used to measure HbA1c, which aids in the management and treatment of diabetes but does not directly treat or prevent a disease.
Yes
The device is designed for "In Vitro Diagnostic Use Only" for the quantitative measurement of Hemoglobin A1c (HbA1c), and HbA1c measurement is used in the "management and treatment of diabetes," which clearly indicates its role in diagnosing and monitoring a medical condition.
No
The device description clearly outlines a physical test kit ("ST AIA-PACK HbA1c test cups") and a chemical process ("enzyme immunoassay," "pretreatment," "magnetic beads," "enzyme-labeled sheep anti-HbA1c polyclonal antibody," "fluorogenic substrate"). This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "ST AIA-PACK HbA1c is designed for In Vitro Diagnostic Use Only". This is the most direct indicator.
- Measurement of Analyte: The device measures the quantitative concentration of Hemoglobin A1c (HbA1c) in a biological sample (EDTA whole blood). This is a key characteristic of an IVD.
- Clinical Purpose: The measurement of HbA1c is used in the "management and treatment of diabetes," indicating a clinical purpose for the test results.
- Sample Type: The device uses a biological sample (whole blood) that is taken from the human body.
- Methodology: The device employs an enzyme immunoassay, a common technique used in IVD tests to detect and quantify specific substances in biological samples.
- Performance Studies: The document describes performance studies (correlation, recovery, precision) conducted to validate the accuracy and reliability of the device for its intended use, which is standard practice for IVDs.
- Predicate Device: The mention of a predicate device (Tosoh Automated Glycohemoglobin Analyzer HLC-723G7) with a K number (K011434) suggests a regulatory submission process, which is required for IVDs.
All of these factors strongly indicate that the ST AIA-PACK HbA1c is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ST AIA-PACK HbA1c is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
Product codes
LCP, JIT, JJY
Device Description
The ST AIA-PACK HbA1c is an enzyme immunoassay which, after pretreatment, is performed entirely in ST AIA-PACK HbA1c test cups. The whole blood sample must first be pretreated prior to immunocomplex formation between HbA1c and sheep anti-HbA1c polyclonal antibody. Sample pretreatment is performed to achieve complete hemolysis of erythrocytes and to expose carbohydrate part of HbA1c in the whole blood sample using ST AIA-PACK HbA1c PRETREATMENT SOLUTION (40 °C, 20 minutes). HbA1c present in the pretreated test sample is captured on the magnetic beads along with hemoglobin and bound with enzyme-labeled sheep anti-HbA1c polyclonal antibody in the AIA-PACK test cup. The beads are washed to remove the unbound materials and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled polyclonal antibody that binds to the beads is directly proportional to the HbA1c concentration in the test sample. A standard curve using a range of known standard percent concentrations aligned to NGSP % is constructed and unknown HbA1c percent concentrations are calculated using this curve.
The following products are required to use the Tosoh AIA-PACK HbA1c.
ST AIA-PACK HbA1c CALIBRATOR SET ST AIA-PACK HbA1c PRETREATMENT SOLUTION AIA-PACK HbA1c CONTROL SET
Mentions image processing
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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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Analysis (Correlation)
The correlation study between Tosoh Automated Glycohemoglobin Analyzer HLC-723G7 (HPLC method) NGSP % (x) and ST AIA-PACK HbA1c NGSP % (y) was carried out using 126 patient specimens.
Regression Analysis (Deming): Slope: 1.027 (1.006 to 1.047), Intercept: -0.168 (-0.326 to -0.011), Corr Coef (R): 0.99, Bias: 0.025, Points: 126/126, Result Ranges: 3.0 to 13.9% (AIA-1800); 2.8 to 14.6% (G7).
Regression Analysis (Regular): Slope: 1.020 (1.000 to 1.040), Intercept: -0.120 (-0.277 to -0.037).
Recovery
A recovery study was performed for ST AIA-PACK HbA1c to support the measuring range of 3-14%*. The maximum recovery was 2.2% and the minimum recovery was -4.9%.
Precision
Precision was assessed by assaying three levels of unaltered EDTA whole blood specimens. Estimates of total and within-run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days. This equaled to a total of 40 runs and 80 determinants.
-
Within Run Precision: CV (%) ranged from 1.1 to 1.9% across three specimen levels (HWB-1, HWB-2, HWB-3) and three reagent sets.
- HWB-1 (Mean 5.3-5.5%): CV 1.6-1.8%
- HWB-2 (Mean 8.1-8.2%): CV 1.1-1.7%
- HWB-3 (Mean 13.0-13.1%): CV 1.5-1.9%
-
Total Precision: CV (%) ranged from 1.9 to 4.0% across three specimen levels (HWB-1, HWB-2, HWB-3) and three reagent sets.
- HWB-1 (Mean 5.3-5.5%): CV 2.0-3.3%
- HWB-2 (Mean 8.1-8.2%): CV 1.9-3.2%
- HWB-3 (Mean 13.0-13.1%): CV 2.4-4.0%
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.
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
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
AUG 27 2010
Section 5
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510(K) Summary
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从100304
HbAlc
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1
Tosoh Bioscience, Inc.
| 510k Summary | AUG 27 2010 | |
|---|---|---|
| Tosoh ST AIA-PACK HbA1c | ||
| Date: | August 20, 2010 | |
| Submitter: | Tosoh Bioscience, Inc. | |
| 3600 Gantz Road | ||
| Grove City, OH 43123 | ||
| 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: | ST AIA-PACK HbA1c | |
| Classification Name: | Class II | |
| LCP | ||
| 21 CFR 864.7470 Glycosylated Hemoglobin Assay | ||
| Predicate Device: | K011434 | |
| Tosoh Automated Glycohemoglobin Analyzer | ||
| HLC-723G7 | ||
| Manufactured by Tosoh Corporation. |
HbAlc
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Section 5
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2
510(k) Summary
ST AIA-PACK HbA1c
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 ST AIA-PACK HbA1c is an enzyme immunoassay which, after pretreatment, is performed entirely in ST AIA-PACK HbA1c test cups. The whole blood sample must first be pretreated prior to immunocomplex formation between HbA1c and sheep anti-HbA1c polyclonal antibody. Sample pretreatment is performed to achieve complete hemolysis of erythrocytes and to expose carbohydrate part of HbA1c in the whole blood sample using ST AIA-PACK HbA1c PRETREATMENT SOLUTION (40 °C, 20 minutes). HbA1c present in the pretreated test sample is captured on the magnetic beads along with hemoglobin and bound with enzyme-labeled sheep anti-HbA1c polyclonal antibody in the AIA-PACK test cup. The beads are washed to remove the unbound materials and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled polyclonal antibody that binds to the beads is directly proportional to the HbA1c concentration in the test sample. A standard curve using a range of known standard percent concentrations aligned to NGSP % is constructed and unknown HbA1c percent concentrations are calculated using this curve.
The following products are required to use the Tosoh AIA-PACK HbA1c.
ST AIA-PACK HbA1c CALIBRATOR SET ST AIA-PACK HbA1c PRETREATMENT SOLUTION AIA-PACK HbA1c CONTROL SET
Device Intended Use:
ST AIA-PACK HbA1c is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
HbAlc
Section 5
3
Substantial Equivalence:
Similarities between ST AIA-PACK HbA1c and Tosoh Automated Glycohemoglobin Analyzer HLC-723G7
| Specifications | ST AIA-PACK HbA1c | Tosoh Automated
Glycohemoglobin
Analyzer HLC-723G7
K011434 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use | ST AIA-PACK HbA1c is designed
for In Vitro Diagnostic Use Only for
the quantitative measurement for
percent concentration of
Hemoglobin A1c (HbA1c) in EDTA
whole blood on Tosoh AIA System
Analyzer. HbA1c measurement is
used in the management and
treatment of diabetes. | Tosoh Automated
Glycohemoglobin
Analyzer HLC-723G7
K011434 |
| Sample Type | EDTA whole blood | EDTA whole blood |
| Assay Range | 3.0 to 14% | 3.0 to 18.4% |
| Reference Range | 3.8 to 6.0% for persons without
diabetes | 4.2 to 5.8% |
| Calibrator Set | ST AIA-PACK HbA1c Calibrator Set 6
point aligned to IFCC and NGSP | Hemoglobin A1c Calibrator
Set 2 point aligned to IFCC
and NGSP K011434 |
| Cross reactivity to Hb
variants HbC, HbD | NO | NO |
Differences between ST AIA-PACK HbA1c and Tosoh Automated Glycohemoglobin Analyzer HLC-723G7
| Specifications | ST AIA-PACK HbA1c | Tosoh Automated
Glycohemoglobin
Analyzer HLC-723G7
K011434 |
|------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Methodology | Immuno Enzymometric Assay
(IEMA) using fluorescence detection | HPLC Method |
| Assay time | 38 minutes (10 min. incubation and
20 min. pretreatment) | 2.2 minutes. |
| Cross reactivity with
HbF | >10% of HbF | 15% |
| Cross reactivity with
HbS | 1 out 5 variant HbS specimens was
outside the criteria of +/- 10%
recovery. | NO |
4
Comparative Analysis (Correlation)
The correlation for ST AIA-PACK HbA1c was determined based on guidance from CLSI Protocol EP9-A2.
The correlation study between Tosoh Automated Glycohemoglobin Analyzer HLC-723G7 (HPLC method) NGSP % (x) and ST AIA-PACK HbA1c NGSP % (y) was carried out using 126 patient specimens.
| Regression Analysis | ||
|---|---|---|
| Deming | Regular | |
| Slope: | 1.027 (1.006 to 1.047) | 1.020 (1.000 to 1.040) |
| Intercept: | -0.168 (-0.326 to -0.011) | -0.120 (-0.277 to -0.037) |
| 95% Confidence Intervals are shown in parentheses | ||
| Corr Coef (R): | 0.99 | |
| Bias: | 0.025 | |
| Points (Plotted/Total): | 126/126 | |
| Result Ranges: | 3.0 to 13.9% (AIA-1800); 2.8 to 14.6% (G7) |
Recovery
A recovery study was performed for ST AIA-PACK HbA1c to support the measuring range of 3-14%* based on guidance from CLSI Protocol EP6-A. The maximum recovery was 2.2% and the minimum recovery was -4.9%.
Image /page/4/Figure/8 description: The image shows a scatter plot titled "Recovery". The x-axis is labeled "Expected value (%)", and the y-axis is labeled "Measured value (%)". A linear trendline is plotted through the data, and the equation of the line is y = 1.024x - 0.104, with an R-squared value of 0.999.
*: HbA1c (NGSP %)
Note: High sample and low sample have the same hemoglobin concentration (approximately 14 g/dL).
Section 5
HbA1c
5
Precision
The precision for ST AIA-PACK HBA1c was determined based on guidance from CLSI Protocol EP5-A2.
Precision was assessed by assaying three levels of unaltered EDTA whole blood specimens. Estimates of total and within-run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days. This equaled to a total of 40 runs and 80 determinants.
Within Run Precision
| Specimen | Reagent Set # 1 | Reagent Set # 2 | Reagent Set # 3 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | |||||||||
| (%)* | Pooled | ||||||||
| SD (%)* | CV | ||||||||
| (%) | Mean | ||||||||
| (%)* | Pooled | ||||||||
| SD (%)* | CV | ||||||||
| (%) | Mean | ||||||||
| (%)* | Pooled | ||||||||
| SD (%)* | CV | ||||||||
| (%) | |||||||||
| HWB-1** | 5.3 | 0.096 | 1.8 | 5.5 | 0.099 | 1.8 | 5.5 | 0.090 | 1.6 |
| HWB-2** | 8.1 | 0.093 | 1.1 | 8.2 | 0.137 | 1.7 | 8.2 | 0.122 | 1.5 |
| HWB-3** | 13.1 | 0.244 | 1.9 | 13.0 | 0.192 | 1.5 | 13.0 | 0.204 | 1.6 |
Within-run precision was determined to be from 1.1 to 1.9%
*(%): HbA1c (NGSP%), ** HWB: Unaltered Human EDTA Whole Blood Specimen.
6
Total precision
| Specimen | Reagent Set # 1 | Reagent Set # 2 | Reagent Set # 3 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | |||||||||
| (%)* | Pooled | ||||||||
| SD (%)* | CV | ||||||||
| (%) | Mean | ||||||||
| (%)* | Pooled | ||||||||
| SD (%)* | CV | ||||||||
| (%) | Mean | ||||||||
| (%)* | Pooled | ||||||||
| SD (%)* | CV | ||||||||
| (%) | |||||||||
| HWB-1** | 5.3 | 0.175 | 3.3 | 5.5 | 0.120 | 2.2 | 5.5 | 0.109 | 2.0 |
| HWB-2** | 8.1 | 0.256 | 3.2 | 8.2 | 0.161 | 1.9 | 8.2 | 0.158 | 1.9 |
| HWB-3** | 13.1 | 0.528 | 4.0 | 13.0 | 0.314 | 2.4 | 13.0 | 0.310 | 2.4 |
Total precision was determined to be from 1.9 to 4.0%
*(%): HbAlc (NGSP%), ** HWB: Unaltered Human EDTA Whole Blood Specimen.
Limit of Detection (LoD) and Limit of Quantitation (LoQ):
This section is not applicable.
Standards:
| Number | FDA
Recognition
Number | Revision | Title |
|-----------------|------------------------------|----------|-----------------------------------------------------------------------------------------------------------------------|
| C28-A3
NCCLS | 7-202 | 09/08/09 | 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 |
7
K 100 304
Tosoh Bioscience, Inc.
Conclusion:
The Tosoh Bioscience, Inc. ST AIA-PACK HbA1c ASSAY is substantially equivalent to the Tosoh Automated Glycohemoglobin Analyzer HLC-723G7 (K011434), for the quantitative measurement of HbA1c in EDTA whole blood samples.
HbAlc
Section S
8 of 8
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Tosch Bioscience, Inc. c/o Ms. Judy Ogden 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 2 7 2010
Re: K100304
Trade/Device Name: Tosoh ST AIA-PACK HbA1c Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIT, JJY Dated: August 5, 2010 Received: August 6, 2010
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 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. :
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
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
510(k) Number (if known):
Device Name:
Indication For Use:
K106304
Tosoh ST AIA-PACK HbA1c
ST AIA-PACK HbA1c is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement for percent concentration of Hemoglobin Alc (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
Prescription Use 2 (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 (OVD)
Doug Rheinben.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
100304
11
510(k) Number (if known):
Device Name:
Indication For Use:
The ST AIA-PACK HbA1c CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of ST AIA-PACK HbA1c Assay.
Tosoh ST AIA-PACK HbA1c Calibrator Set
Prescription Use _____________________________________________________________________________________________________________________________________________________________ く (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 (OVD)
Doug Thenken
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
12
510(k) Number (if known):
Device Name:
Indication For Use:
The AIA-PACK HbA1c CONTROL SET is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK HbA1c Assay.
Tosoh ST AIA-PACK HbAlc Control Set
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)
Doug Rheinheim
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K100 304
13
510(k) Number (if known):
Device Name:
Tosoh ST AIA-PACK HbAlc Pretreatment Solution
Indication For Use: .
The ST AIA-PACK HbA1c PRETREATMENT SOLUTION is intended for IN VITRO DIAGNOSTIC USE ONLY for the pretreatment of the patient samples or AIA-PACK HbA1c CONTROL SET for the ST AIA-PACK HbA1c assay.
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 (OVD)
Doug Rheinheim
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety