(515 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring Hemoglobin A1c using enzymatic methods. There is no mention of AI, ML, or any computational techniques beyond standard data processing for quantitative analysis. The focus is on the chemical and enzymatic reactions and the performance characteristics of the assay itself.
No
The device is described as an "in vitro diagnostic assay" which is used to measure Hemoglobin A1c for diagnosis and monitoring of diabetes, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP)... used as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus." This directly indicates its diagnostic purpose.
No
The device description explicitly states the assay consists of three liquid reagents and describes both automated and manual applications involving sample lysis, indicating it is a chemical assay with associated hardware (the ADVIA® Chemistry Systems) and reagents, 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 that the assay is an "in vitro diagnostic assay".
- Sample Type: The assay is designed to be used with "human anticoagulated venous whole blood and hemolysate", which are biological samples tested outside of the body.
- Purpose: The purpose of the assay is for the "quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP)", which is a measurement used to aid in the diagnosis and monitoring of a medical condition (diabetes mellitus).
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA® Chemistry Systems. Measurement of Hemoglobin A1c is used as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
LCP, PDJ
Device Description
The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay measures hemoglobin A1c in human anticoagulated whole blood and hemolysate. The assay consists of three reagents (R1, R2, and Pretreatment Solution), which are liquid and ready to use.
The assay offers both an automated and a manual application. The automated application (A1c_E) lyses the anticoagulated whole blood specimen on the system for the automated application (A1c E). Samples may also be lysed manually using the ADVIA® Chemistry A1c_E Pretreatment Solution to obtain hemolysate for the manual application (A1c_EM). The two applications yield the same results.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
A risk analysis and verification activities were conducted as part of design control activities.
A risk analysis was conducted in accordance with ISO 14971:2012 standard, Medical Devices – Application of Risk Management to Medical Devices to identify and assess the risks associated with the device modification described in this submission and the risks associated with compliance to the FDA Special Controls set forth in 21 CFR 862.1373(b).
The normal condition and fault condition/failure mode were identified for each risk. Risk mitigations were identified, and effectiveness confirmed through verification activities.
Based on the risk analysis, risk mitigations identified were verified for effectiveness in accordance with relevant standards and established protocols with predetermined acceptance criteria. Testing verified all acceptance criteria were met.
The verification study of linearity was done in accordance with the CLSI standard recognized by the FDA. This study along with other verification activities demonstrate equivalent performance to the predicate and effective risk mitigations. The studies met pre-determined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 862.1373 Hemoglobin A1c test system.
(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.
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July 2, 2021
Siemens Healthcare Diagnostics, Inc. Julie Warren Regulatory Affairs Professional 511 Benedict Avenue Tarrytown, New York 10591
Re: K200256
Trade/Device Name: ADVIA® Chemistry Enzymatic Hemoglobin Ale (Alc E) Assay Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP, PDJ Dated: October 12, 2020 Received: October 14, 2020
Dear Julie Warren:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200256
Device Name
ADVIA® Chemistry Enzymatic Hemoglobin Ale (Alc E) Assay
Indications for Use (Describe)
The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA® Chemistry Systems. Measurement of Hemoglobin A 1 c is used as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(k) Summary – K200256
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
1. Submitter
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 USA Establishment Registration Number: 2432235
| Submission Contact Person: | Julie Warren |
|---|---|
| Phone: | (302) 631-8722 |
| Email: | julie.warren@siemens-healthineers.com |
| Facsimile: | (302) 631-6299 |
| Date of Preparation | June 17, 2021 |
2. Device Information
Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare professional. For in vitro diagnostic use.
| Proprietary Name | ADVIA® Chemistry Enzymatic Hemoglobin A1c
(A1c_E) Assay | |
|----------------------|------------------------------------------------------------|--------------------------------|
| Common or Usual Name | Hemoglobin A1c Test System | Assay, Glycosylated Hemoglobin |
| Classification Name | Hemoglobin A1c Test System | Glycosylated hemoglobin assay |
| Regulation | 21 CFR 862.1373 | 21 CFR 864.7470 |
| Classification | Class II | Class II |
| Product Code | PDJ | LCP |
| Review Panel | Clinical Chemistry | Hematology |
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3. Device Description
The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay measures hemoglobin A1c in human anticoagulated whole blood and hemolysate. The assay consists of three reagents (R1, R2, and Pretreatment Solution), which are liquid and ready to use.
The assay offers both an automated and a manual application. The automated application (A1c_E) lyses the anticoagulated whole blood specimen on the system for the automated application (A1c E). Samples may also be lysed manually using the ADVIA® Chemistry A1c_E Pretreatment Solution to obtain hemolysate for the manual application (A1c_EM). The two applications yield the same results.
4. Intended Use/Indications for Use
The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA® Chemistry Systems. Measurement of Hemoglobin A1c is used as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus.
5. Reason for Submission
This Special 510(k) is being filed to seek FDA clearance of a modification to the ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) assay to extend the low end of the analytical measuring range of total hemoglobin (tHb).
A Special 510(k) Premarket Notification is the requested pathway because the following:
- . There is no change to the intended use or indications for use.
- There is no change in the fundamental scientific technology.
- There is no change to the principle of operation.
- . There is no change to the formulation.
- There is no change to the instrument parameters related to sample volume, reagent volume, mix speed, wavelengths, or read times.
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6. Medical Device to Which Equivalence is Claimed
The predicate device for this Special 510(k) submission is the ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c_E) assay cleared under K171771 on December 4, 2017. The classification information is as follows.
| Trade Name | Common/Usual Name | Classification | Product
Code | Panel |
|---------------------------------------------------------------|---------------------------------------------------------------------|----------------|-----------------|--------------------------------------|
| ADVIA® Chemistry
Enzymatic Hemoglobin
A1c (A1c_E) Assay | Hemoglobin A1c Test
System;
Assay, Glycosylated
Hemoglobin | Class II | PDJ; LCP | Clinical
Chemistry;
Hematology |
7. Comparison of Technological Characteristics with the Predicate Device
The similarities and differences to the predicate device were compared side by side in the following table.
| Attribute | Predicate Device
ADVIA® Chemistry
Enzymatic Hemoglobin A1c (A1c_E) Assay,
K171771 | Modified Device
ADVIA® Chemistry
Enzymatic Hemoglobin
A1c (A1c_E) Assay |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c_E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated whole blood and hemolysate for use on the ADVIA® Chemistry systems.
Measurement of Hemoglobin A1c is used as an aid in the diagnosis and monitoring of patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus. | Same |
| Attribute | Predicate Device
ADVIA® Chemistry
Enzymatic Hemoglobin A1c (A1c_E) Assay,
K171771 | Modified Device
ADVIA® Chemistry
Enzymatic Hemoglobin
A1c (A1c_E) Assay |
| Technology; Type of Test | Quantitative, enzymatic | Same |
| Measuring Range | 3.8 to 14.0% HbA1c (DCCT/NGSP)
18.03 -129.50 mmol/mol HbA1c (IFCC) | Same |
| Analytical
Measuring Range
for total
hemoglobin | 88.98-320.15 μmol/L | 74.74-320.15 μmol/L |
| Specimen Types | Whole blood and Hemolysate | Same |
| Anticoagulant
Types | Dipotassium EDTA
Lithium Heparin
Sodium Fluoride/Disodium EDTA
Tripotassium EDTA | Same |
| Standardization
and Certification | Assay standardization is traceable to International
Federation of Clinical Chemistry (IFCC) reference
calibrators. Assay is certified with the National
Glycohemoglobin Standardization Program
(NGSP). The NGSP certification must be renewed
annually. | Same |
| Instrument
Platform | ADVIA® 1800 Clinical Chemistry System | Same |
| Reporting Units | % HbA1c NGSP/DCCT and mmol/mol IFCC | Same |
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8. Summary of Design Control Activities
A risk analysis and verification activities were conducted as part of design control activities.
8.1 Risk Analysis
A risk analysis was conducted in accordance with ISO 14971:2012 standard, Medical Devices – Application of Risk Management to Medical Devices to identify and assess the risks associated with the device modification described in this submission and the risks associated with compliance to the FDA Special Controls set forth in 21 CFR 862.1373(b).
The normal condition and fault condition/failure mode were identified for each risk. Risk mitigations were identified, and effectiveness confirmed through verification activities.
8.2 Verification Activities
Based on the risk analysis, risk mitigations identified were verified for effectiveness in accordance with relevant standards and established protocols with predetermined acceptance criteria. Testing verified all acceptance criteria were met.
9. Conclusion
The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) Assay modified device is substantially equivalent to the predicate in intended use/indications for use, fundamental technology, principle of operation, formulation, and method parameters related to sample and reagent volume, mix speed, wavelengths, and read times.
The change to the device was to extend the low end of the measuring range for total hemoglobin (tHb). The change is to Siemens Healthcare Diagnostics Inc. own device. Performance data were needed to evaluate the change. Risk analysis and verification activities were performed as part of design control activities.
The risks identified to the assay Special Controls set forth in 21 CFR 862.1373(b) and the device modification were acceptable and mitigations are effective. The verification study of linearity was done in accordance with the CLSI standard recognized by the FDA. This study along with other verification activities demonstrate equivalent performance to the predicate and effective risk mitigations. The studies met pre-determined acceptance criteria.
ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) Assay Siemens Healthcare Diagnostics Inc.
510(k) Summary Page 5 of 6
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Results from design control activities including the risk analysis and the verification activities support substantial equivalence between the change device and the predicate. The changes to not impact the safety or effectiveness of the device.