Who is the manufacturer of GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY?

Beckman Coulter, Inc. filed the 510(k) submission for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY (K120199).

What is the FDA product code for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY?

LCP. It is classified under 21 CFR 864.7470 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY?

Synchron Systems Hemoglobin A1c reagent (k010748).

Who can help prepare an FDA 510(k) submission like GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

K120199 · Beckman Coulter, Inc. · LCP · Oct 12, 2012 · Hematology

Device Facts

Record ID	K120199
Device Name	GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
Applicant	Beckman Coulter, Inc.
Product Code	LCP · Hematology
Decision Date	Oct 12, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7470
Device Class	Class 2

Intended Use

The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must not be used individually for diagnostic purposes. The HbA1c Calibrators are an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems. Measurement of hemoglobin A1c is accepted as a method to measure longterm glucose control in patients with diabetes mellitus.

Device Story

The AU Systems HbA1c Test System is an in vitro diagnostic assay for use on Beckman Coulter AU clinical chemistry analyzers. It utilizes human whole blood samples, which are manually pre-treated with a hemolyzing reagent containing tetradecyltrimethylammonium bromide (TTAB) to eliminate leukocyte interference. The system performs two simultaneous measurements: total hemoglobin via a colorimetric method (absorbance at 570/660 nm) and HbA1c via a turbidimetric immunoinhibition method (absorbance at 340/700 nm). In the latter, HbA1c antibodies bind to sample HbA1c, and polyhaptens bind excess antibodies to form agglutinated complexes measured turbidimetrically. The device outputs the HbA1c/Total Hemoglobin ratio in mmol/mol (IFCC) or %HbA1c (NGSP). Used in clinical laboratory settings by trained personnel, the results assist healthcare providers in assessing glycemic control over the preceding 2-3 months, aiding in the management of diabetes mellitus and the prevention of long-term complications.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (n=80 for controls, n=15 for patient pools) showing total CVs <2.8%. Linearity confirmed 4-15% range. Interference studies (bilirubin, triglycerides, RF, ascorbic acid, labile A1c, carbamylated Hb, acetylsalicylic acid) showed <10% bias. Hemoglobin variant study (C, D, E, S, F) showed <10% bias. Method comparison (n=130) against predicate showed high correlation (R >0.99).

Technological Characteristics

Turbidimetric inhibition immunoassay; colorimetric total hemoglobin measurement. Reagents: Total Hemoglobin R1, HbA1c R1, HbA1c R2, Hemolyzing Reagent (tetradecylmethyammonium bromide). Calibrators: Lyophilized human/sheep hemolysate. Analyzers: AU480, AU680, AU2700. Connectivity: Integrated into clinical chemistry analyzer workflow. Standards: CLSI EP05-A2, EP06-A, EP07-A2, EP09-A2-IR, EP17-A.

Indications for Use

Indicated for the quantitative determination of hemoglobin A1c in human whole blood to monitor long-term glucose control in patients with diabetes mellitus.

Regulatory Classification

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.

Predicate Devices

Synchron Systems Hemoglobin A1c reagent (k010748)

Related Devices

K182651 — HbA1c Advanced · Beckman Coulter Ireland, Inc. · Jan 16, 2019
K063306 — ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 · Alfa Wassermann, Inc. · Apr 17, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ K120199 OCT 1 2 2012 Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved white lines inside, placed to the left of the company name. The text "BECKMAN" is stacked on top of "COULTER" in a bold, sans-serif font. 510k Summary AU® Systems HbA1c (Hemoglobin) Test System #### 1.0 Submitted By: Bev Harding Sr. Regulatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 Telephone: 972-831-3656 Fax: 972-831-3684 Email: bbharding@beckman.com #### 2.0 Date Submitted: January 20, 2012 #### 3.0 Device Name(s): #### 3.1 Proprietary Names AU® Systems HbA1c (Hemoglobin) Test System #### 3.2 Classification Name Glycosylated hemoglobin assay (21 CFR § 864.7470) #### 4.0 Predicate Device: | Candidate(s) | Predicate | Manufacturer | Docket Number | |--------------------------------------------------|-------------------------------------------------------|-------------------------|------------------| | AU® Systems HbA1c (Hemoglobin) Test System | SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent | Beckman Coulter, Inc | K010748 | #### 5.0 Description: The HbA1c assay (B00389) involves the use of four reagents: Total Hemoglobin R1, HbA1c R1, HbA1c R2, and Hemolyzing Reagent (sold separately as Cat. No. 472137). In a pre-treatment step, whole blood is mixed with the Hemolyzing Reagent in a 1 to 100 dilution and the resultant hemolysate is used. Tetradecyltrimethylammonium bromide (TTAB) in the Hemolyzing Reagent eliminates interference from leukocytes. {1}------------------------------------------------ The concentrations of both HbA1c and Total Hemoglobin are determined. The HbA1c/Total Hemoglobin ratio is expressed either as mmol/mol (IFCC) or %HbA1c (DCCT/NGSP). Total Hemoglobin Reagent is used to measure total hemoglobin concentration by a colorimetric method. Change is absorbance is measured at 570/660 nm. HbA1c reagent is used to measure hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, hemoglobin A1c antibodies combine with HbA1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. Change in absorbance is measured at 340/700 nm. #### 6.0 Intended Use: The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must not be used individually for diagnostic purposes. The HbA1c Calibrators are an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems. Measurement of hemoglobin A1c is accepted as a method to measure longterm glucose control in patients with diabetes mellitus. ### Clinical Significance: Measurement of hemoglobin A1c is accepted as a method to measure longterm glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin A1c provides an important tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus. Long term treatment of the disease emphasizes control of blood glucose levels in preventing the acute complications of ketosis and hyperglycemia. In addition, long term complications such as retinopathy, neuropathy, and cardiovascular disease can be minimized if blood glucose levels are effectively controlled. The process of conversion from hemoglobin A to hemoglobin A1c depends on the blood glucose concentration. Since the average life of a red blood cell is 120 days, measurement of hemoglobin A1c can reflect the mean daily blood glucose concentration over the preceding two to three months and provides a much better indication of glycemic control than blood or urinary glucose determinations. {2}------------------------------------------------ #### 7.0 Comparison to Predicate(s): The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary. | Feature | Predicate Device: K010748 | New Device: | Similarities | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The hemoglobin a1c reagent kit, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 600/800 System(s), SYNCHRON® Systems HbA1c Calibrators and SYNCHRON® Systems Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin a1c concentration as a percentage of total hemoglobin in human wholeblood. | The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For in vitro diagnostic use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must not be used individually for diagnostic purposes. | Similar | | Technology | Colorimetric | Colorimetric | Same | | Methodology | Turbidimetric immunoinhibition | Turbidimetric immunoinhibition | Same | | Specimen Type | Whole blood | Whole blood | Same | | Packaging | Reagents and calibrators in kit; Hemolyzing reagent sold separately. | Reagents and calibrators in kit; Hemolyzing reagent sold separately. | Similar | | Sample Type | Freshly drawn blood treated with EDTA or heparin is the preferred specimen. Details on EDTA. Lithium Heparin, and Sodium heparin are in IFU. | K2-EDTA, K3-EDTA, Li- Heparin or Na-Heparin whole blood (freshly drawn blood treated with EDTA is the preferred specimen). | Similar | | Sample Preparation | Before use, pre-treat samples by manual | Before use, pre-treat samples and controls by | Similar | | | dilution. | manual dilution. | | | Reagent Format and Storage | Liquid Stable 2 - 8°C | Liquid Stable 2 - 8°C | Similar | | Calibrator matrix base | Hemolysate (human and sheep) | Hemolysate (human and sheep) | Same | | Traceability | IFCC HbA1c Reference Method. Process based on prEN ISO 17511. Data is converted to NGSP units via the use of the Master Equation. | IFCC HbA1c Reference Method. Data is converted to NGSP units via the use of the Master Equation. | Similar | | Certification | NGSP certified | NGSP certified | Similar | | Reference Interval | Literature 4.0 - 6.0% HbA1c SYNCHRON 4.6-2.6% HbA1c | 4.0 - 6.0% HbA1c | Performance data within the submission supports substantial equivalence and reference interval. | | Interfering Substances | No significant interference (within ± 0.80% HbA1c or 10%) Bilirubin (unconjugated) 30 mg/dL Lipemia 400 mg/dL RF 3000 IU/ml Ascorbic acid 50 mg/dL Labile glycated hemoglobin ≤10% up to 1000 mg/dL (5 hours at 37°C) Cross reactivity and Hb Variants interference data also presented in IFU. | Bilirubin ≤6% up to 30 mg/dL Lipemia ≤6% up to 400 mg/dL Intralipid® RF ≤6% up to 1000 IU/mL Ascorbic Acid ≤6% up to 50 mg/dL Labile glycated hemoglobin ≤10% up to 2000 mg/dL (5 hours at 37°C) Cross reactivity and Hb Variants interference data also presented in IFU | Similar | | Feature | Predicate Device: | New Device: | Differences | | Precision | Within 5.0% Total 7.5 % | Within 4.0% Total 4.0% | Different Performance data within the submission supports improved precision and substantial equivalence of the new test system. | | Analytical Measuring Range | 2 - 20% HbA1c | 4 - 15% HbA1c (NGSP)/20 - 140 mmol/mol (IFCC) | Different NGSP units are reported as %HbA1c; IFCC units are reported as mmol/mol. Method comparison and linearity data helped support extending the range on the AU HbA1c. | | Instrument | SYNCHRON LX® System(s), UniCel® DxC 600/800 System(s), SYNCHRON® Systems | Models of AU analyzers | Different The AU analyzer data within the submission supports the substantial equivalence for AU480, AU680 and the AU2700 Beckman Coulter Analyzers. | | Calibrator Format and Levels | Lyophilized 5 levels Hb = single point A1c = multi point | Lyophilized 5 levels THb = two point HbA1c = multi point | Different The number of calibrators used is method- specific. Performance data within the | | | | | | | Pre-treatment Reagent | SYCHRON Hemolyzing Reagent 1000 μL hemolyzing reagent in test tube Add exactly 10 μL of whole blood sample | SYCHRON and AU Hemolyzing Reagent Ratio 1 to 100 dilution Pre-treatment - until hemolysis is complete (approx. 1-2 minutes). | submission supports substantial equivalence of the calibrators and new reagents. Different Performance data within the submission supports substantial equivalence. | | Stability | Calibrator & Reagent unopened store at 2° to 8°C until expiration date Calibrator reconstituted = 8 hours 15°- 25°C 48 hours at 2°- 8°C unless expiration date is exceeded Open hemoglobin reagent stable 60 days at 2°-8°C unless exp. date exceeded. Open A1c reagent stable 30 days at 2°- 8°C unless exp. date exceeded. | Calibrator & Reagent unopened store at 2° to 8°C until expiration date Calibrator reconstituted = up to 8 hours at 15 - 25°C up to 30 hours at 2 - 8°C up to 30 days at - 20 °C. Calibration Stability = 14 days Reagent on-board = 30 days Kit Shelf Life Stability = 18 months at launch | Different Stability data within the submission supports new claims. | | Reporting Units | SYNCHRON calculations IFCC HbA1c concentration in percent. Must use calculation in IFU that converts IFCC to NGSP. | % HbA1c (NGSP) and mmol/mol (IFCC) | Different IFCC /IUPAC committee updated their recommend- ations on HbA1c units and nomenclature in 2007. | | Sensitivity | Sensitivity is defined as the lowest measurable concentration which can be distinguished from | THb: LoB = 0.05 mmol/L (0.09 g/dL); LoD = 0.10 mmol/L (0.16 g/dL) | Different Sensitivity for the new device | | | | | | | | zero with 95% confidence. Sensitivity for the total hemoglobin determination is 6 g/dL. Sensitivity for the A1c determination is 0.3 g/dL. | g/dL). HbA1c: LoB = 0.12 mmol/L (0.19 g/dL); LoD = 0.13 mmol/L (0.22 g/dL). | refers to LoB and LoD, rather than general sensitivity. Performance data within the submission supports substantial equivalence and new claim. | | Specimen Storage and Stability | Whole blood samples stable for: No longer than 7 days at 2 - 8°C 3 months at -15 C to - 20°C Hemolysate stable 4 hours at room temperature and 24 hours at 2° to 8°C | Samples (non-pretreated) are stable up to 8 hours when stored at 25°C, 7 days when stored at 2...8°C and up to 3 months when frozen at - 20°C. Whole blood samples are stable for 18 months at -70°C Hemolyzed (pre-treated) samples are stable up to 4 hours when stored at 15...25°C, up to 24 hours when stored at 2...8°C, if stored in a sealed container. | Different Stability data within the submission supports substantial equivalence and new claims. | Beckman Coulter, Inc. 250 S. Kraemer Boulevard Brea, CA 92821 Telephone: (714) 993-53321 Facsimile: (714) 961-4234 Internet: www.beckmancoulter.com {3}------------------------------------------------ Beckman Coulter, Inc. 250 S. Kraemer Boulevard Brea, CA 92821 . . Telephone: (714) 993-5321 Facsimile: (714) 961-4234 Internet: (714) 961-4234 Internet: www.beckmancoulter.com ・ , {4}------------------------------------------------ Beckman Coulter, Inc. 250 S. Kraemer Boulevard Brea, CA 92821 . ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- . {5}------------------------------------------------ . Beckman Coulter, Inc. 250 S. Kraemer Boulevard Brea, CA 92821 Telephone: (714) 993-5321 Facsimile: (714) 961-4234 Internet: www.beckmancoulter.com {6}------------------------------------------------ #### 8.0 Summary of Performance Data: Based on the performance testing the AU® Systems HbA1c (Hemoglobin) Test System is substantially equivalent to the predicate device. {7}------------------------------------------------ ## Method Comparison Study Results · | Candidate | Slope | Intercept | R | N | Predicate Method | |-------------------------|-------|-----------|--------|-----|-------------------------------------------------------------| | AU HbA1c Test System | 0.901 | 0.3140 | 0.9941 | 130 | SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent | ## AU HbA1c Test System Precision Study Results | TYPE OF IMPRECISION | SAMPLE TYPE | No. of Data Points | Mean %HbA1c | CV% | SD (%HbA1c) | |------------------------|------------------------------|--------------------------|----------------|------|----------------| | Within run | Hemolysate Control Pool 1 | 80 | 5.3 | 1.44 | 0.08 | | | Hemolysate Control Pool 2 | 80 | 7.4 | 1.03 | 0.08 | | | Hemolysate Control Pool 3 | 80 | 9.4 | 1.03 | 0.10 | | Total | Hemolysate Control Pool 1 | 80 | 5.3 | 2.07 | 0.11 | | | Hemolysate Control Pool 2 | 80 | 7.4 | 1.84 | 0.14 | | | Hemolysate Control Pool 3 | 80 | 9.4 | 1.68 | 0.16 | This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. Beckman Coulter, Inc. 250 S. Kraemer Boulevard Brea, CA 92821 {8}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract bird or wing-like design. The seal is black and white and appears to be a logo or official symbol. ## Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Beckman Coulter, Inc c/o Beverly Harding 250 S. Kraemer Blvd. Mail Stop A2 SW.08 Brea, California 92821 Re: k120199 > Trade Name: AU® Systems HbA1c (Hemoglobin A1c) Test System Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Codes: LCP, JIT Dated: September 11, 2012 Received: September 13, 2012 Dear Ms. Harding: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). OCT 12 2012 {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 Devices and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, prouse meter to regarding postmarket surveillance, please contact CDRH S Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ... You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 638-2041 or (301) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm Sincerely yours, f Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ ## Indication for Use # 510(k) Number (if known): K 12019 9 Device Name: AU® Systems HbA1c (Hemoglobin A1c) Test System Indication For Use: The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must be not used individually for diagnostic purposes. The HbA1c Calibrators is an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems. Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus. Prescription Use _ X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) And/Or Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Rattin Sussa Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 120199

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!