(263 days)
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.
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.
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.
Here's an analysis of the provided 510(k) summary for the Beckman Coulter AU® Systems HbA1c (Hemoglobin) Test System, broken down by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent, K010748), primarily focusing on aspects like precision, analytical measuring range, and method correlation. The summary doesn't explicitly state quantitative "acceptance criteria" separate from the "reported device performance," but rather presents the performance data to show it meets or improves upon the predicate.
| Performance Metric | Acceptance Criteria (Implied by Predicate/Regulatory Expectations) | Reported Device Performance (AU Systems HbA1c Test System) |
|---|---|---|
| Precision (Within Run CV%) | ≤ 5.0% for predicate (Within Run) | Control Pool 1 (5.3% HbA1c): 1.44% |
| Control Pool 2 (7.4% HbA1c): 1.03% | ||
| Control Pool 3 (9.4% HbA1c): 1.03% | ||
| Precision (Total CV%) | ≤ 7.5% for predicate (Total) | Control Pool 1 (5.3% HbA1c): 2.07% |
| Control Pool 2 (7.4% HbA1c): 1.84% | ||
| Control Pool 3 (9.4% HbA1c): 1.68% | ||
| Analytical Measuring Range | 2 - 20% HbA1c (Predicate) | 4 - 15% HbA1c (NGSP) / 20 - 140 mmol/mol (IFCC) |
| Method Comparison (Slope vs. Predicate) | Close to 1.0 | 0.901 |
| Method Comparison (Intercept vs. Predicate) | Close to 0 | 0.3140 |
| Method Comparison (Correlation Coefficient R vs. Predicate) | High (e.g., >0.95 or >0.97) | 0.9941 |
| Interfering Substances | No significant interference (within ± 0.80% HbA1c or 10%) for predicate on tested substances (Bilirubin, Lipemia, RF, Ascorbic acid, Labile glycated hemoglobin) | Bilirubin ≤6% up to 30 mg/dLLipemia ≤6% up to 400 mg/dL Intralipid®RF ≤6% up to 1000 IU/mLAscorbic Acid ≤6% up to 50 mg/dLLabile glycated hemoglobin ≤10% up to 2000 mg/dL (5 hours at 37°C) |
| Sensitivity (LoB/LoD) | Defined for predicate (e.g., Total Hb 6 g/dL, A1c 0.3 g/dL) | THb: LoB = 0.05 mmol/L (0.09 g/dL); LoD = 0.10 mmol/L (0.16 g/dL)HbA1c: LoB = 0.12 mmol/L (0.19 g/dL); LoD = 0.13 mmol/L (0.22 g/dL) |
Notes on Acceptance Criteria:
- The summary explicitly states: "Performance data within the submission supports improved precision and substantial equivalence of the new test system." This indicates that the new device's precision (Total CV% of ≤4.0% vs. predicate's ≤7.5%) is better than the predicate, thus meeting and exceeding the implicit acceptance criteria inferred from predicate performance.
- For the Analytical Measuring Range, the new device has a slightly different range (4-15% vs 2-20%), but the method comparison and linearity data are reported to support extending the range on the AU HbA1c.
- For Interfering Substances and Sensitivity, the data presented also aims to demonstrate "substantial equivalence and new claim."
2. Sample Sizes Used for the Test Set and Data Provenance
- Method Comparison Study:
- Sample Size: N = 130
- Data Provenance: Not explicitly stated (e.g., country of origin). Typically, clinical samples for such studies are collected prospectively or retrospectively from diverse patient populations within a single country or region where the testing is intended. The document does not specify if the data was retrospective or prospective, though method comparison studies often utilize a mix of patient samples to cover the analytical range.
- Precision Study:
- Sample Size: 80 data points for each of 3 control pools. This implies multiple replicates over several days or runs to calculate within-run and total precision.
- Data Provenance: Not explicitly stated. Control pools are typically manufactured materials, not patient samples, designed to represent different analyte concentrations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of in vitro diagnostic device (IVD) for HbA1c measurement does not typically rely on "experts" to establish ground truth for individual test samples in the same way an imaging AI device would. Instead, the "ground truth" or reference values are established through:
- Reference Methods: The device's traceability is stated as "IFCC HbA1c Reference Method." This refers to standardized, highly accurate laboratory methods used to assign target values to calibrators and control materials. These reference methods themselves are meticulously developed and validated by expert committees (e.g., IFCC working groups).
- Predicate Device Comparison: For the method comparison study, the "ground truth" for the 130 samples would be the results obtained from the predicate device (SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent). The predicate device itself would have been validated against IFCC or NGSP (National Glycohemoglobin Standardization Program) reference methods.
Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth for a test set of this nature (chemical assay) is not directly applicable in the same way as for subjective interpretation tasks (like radiology images). The ground truth is rooted in established, standardized analytical methods.
4. Adjudication Method for the Test Set
Not applicable for this type of chemical assay. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in subjective expert interpretations, which is not relevant for quantitative measurements from an automated analyzer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic tool designed to augment human reader performance in a subjective task. There is no "human reader" involved in interpreting the results of the HbA1c test in a way that would necessitate an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is essentially a standalone device performance study. The AU® Systems HbA1c Test System is an automated analyzer designed to provide quantitative results directly from a sample without real-time human interpretive input beyond running the test and validating the instrument's performance. The performance data (precision, method comparison, interference) directly reflects the algorithm/assay's output.
7. The Type of Ground Truth Used
The ground truth for this device's performance studies is based on:
- IFCC HbA1c Reference Method: For traceability and calibration of materials.
- Predicate Device Measurements: For the method comparison study (results from the SYNCHRON Systems HbA1c Reagent).
- Assigned Values for Control Materials: For precision studies, control materials have defined target values established through rigorous testing against reference methods.
8. The Sample Size for the Training Set
Not applicable in the conventional sense of AI/machine learning training sets. This is a traditional chemical assay, not an algorithm that learns from a large dataset. The "training" of such a system involves:
- Method Development & Optimization: Where various reagents, protocols, and instrument settings are empirically optimized.
- Calibration: The system is calibrated using a set of calibrators with established values.
The document doesn't specify a "training set" size as it would for an AI model.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there isn't a "training set" in the AI sense. However, the ground truth for calibration (which could be considered analogous in its role of establishing the system's accuracy) is established through:
- IFCC HbA1c Reference Method: The calibrators for the AU systems HbA1c assay are traceable to the IFCC Reference Method. This means the values assigned to these calibrators are determined using highly accurate, standardized reference procedures.
- NGSP Certification: The device and its calibrators are NGSP certified, which ensures standardization and traceability to the Diabetes Control and Complications Trial (DCCT) reference method. This involves a rigorous process where manufacturers' methods are compared to the NGSP reference network.
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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 | DocketNumber |
|---|---|---|---|
| AU® Systems HbA1c(Hemoglobin) TestSystem | SYNCHRON SystemsHemoglobin A1c(HbA1c) Reagent | BeckmanCoulter, 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.
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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.
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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 a1creagent kit, when used inconjunction withSYNCHRON LX®System(s), UniCel® DxC600/800 System(s),SYNCHRON® SystemsHbA1c Calibrators andSYNCHRON® SystemsHemolyzing Reagent, isintended for thequantitativedetermination ofhemoglobin a1cconcentration as apercentage of totalhemoglobin in humanwholeblood. | The HbA1c (HemoglobinA1c) reagent, when usedin conjunction withBeckman CoulterSystems, HbA1cCalibrators andSYNCHRON and AUHemolyzing Reagent, isintended for thequantitativedetermination ofhemoglobin A1cconcentration in humanwhole blood. For in vitrodiagnostic use only.The absolute HbA1c andTotal Hemoglobin (THb)values generated as partof the HbA1c assay areintended for use in thecalculation of theHbA1c/Total Hemoglobinratio and must not be usedindividually for diagnosticpurposes. | Similar |
| Technology | Colorimetric | Colorimetric | Same |
| Methodology | Turbidimetricimmunoinhibition | Turbidimetricimmunoinhibition | Same |
| Specimen Type | Whole blood | Whole blood | Same |
| Packaging | Reagents and calibratorsin kit; Hemolyzingreagent sold separately. | Reagents and calibratorsin kit; Hemolyzingreagent sold separately. | Similar |
| Sample Type | Freshly drawn bloodtreated with EDTA orheparin is the preferredspecimen. Details onEDTA. Lithium Heparin,and Sodium heparin arein IFU. | K2-EDTA, K3-EDTA, Li-Heparin or Na-Heparinwhole blood (freshlydrawn blood treated withEDTA is the preferredspecimen). | Similar |
| SamplePreparation | Before use, pre-treatsamples by manual | Before use, pre-treatsamples and controls by | Similar |
| dilution. | manual dilution. | ||
| Reagent Formatand Storage | Liquid Stable2 - 8°C | Liquid Stable2 - 8°C | Similar |
| Calibrator matrixbase | Hemolysate (human and sheep) | Hemolysate (human and sheep) | Same |
| Traceability | IFCC HbA1c ReferenceMethod. Process basedon prEN ISO 17511.Data is converted toNGSP units via the useof the Master Equation. | IFCC HbA1c ReferenceMethod. Data isconverted to NGSP unitsvia the use of the MasterEquation. | Similar |
| Certification | NGSP certified | NGSP certified | Similar |
| ReferenceInterval | Literature 4.0 - 6.0%HbA1cSYNCHRON 4.6-2.6%HbA1c | 4.0 - 6.0% HbA1c | Performancedata within thesubmissionsupportssubstantialequivalence andreferenceinterval. |
| InterferingSubstances | No significantinterference (within ±0.80% HbA1c or 10%)Bilirubin (unconjugated)30 mg/dLLipemia 400 mg/dLRF 3000 IU/mlAscorbic acid 50 mg/dLLabile glycatedhemoglobin ≤10% up to1000 mg/dL (5 hours at37°C)Cross reactivity and HbVariants interferencedata also presented inIFU. | Bilirubin ≤6% up to 30mg/dLLipemia ≤6% up to 400mg/dL Intralipid®RF ≤6% up to 1000IU/mLAscorbic Acid ≤6% up to50 mg/dLLabile glycatedhemoglobin ≤10% up to2000 mg/dL (5 hours at37°C)Cross reactivity and HbVariants interferencedata also presented inIFU | Similar |
| Feature | Predicate Device: | New Device: | Differences |
| Precision | Within 5.0%Total 7.5 % | Within 4.0%Total 4.0% | DifferentPerformance data within thesubmission supportsimproved precision andsubstantial equivalence ofthe new test system. |
| AnalyticalMeasuring Range | 2 - 20% HbA1c | 4 - 15% HbA1c(NGSP)/20 - 140mmol/mol (IFCC) | DifferentNGSP units arereported as%HbA1c; IFCCunits arereported asmmol/mol.Methodcomparison andlinearity datahelped supportextending therange on the AUHbA1c. |
| Instrument | SYNCHRON LX®System(s), UniCel® DxC600/800 System(s),SYNCHRON® Systems | Models of AU analyzers | DifferentThe AU analyzerdata within thesubmissionsupports thesubstantialequivalence forAU480, AU680and the AU2700BeckmanCoulterAnalyzers. |
| Calibrator Formatand Levels | Lyophilized5 levelsHb = single pointA1c = multi point | Lyophilized5 levelsTHb = two pointHbA1c = multi point | DifferentThe number ofcalibrators usedis method-specific.Performancedata within the |
| Pre-treatmentReagent | SYCHRON HemolyzingReagent1000 μL hemolyzingreagent in test tubeAdd exactly 10 μL ofwhole blood sample | SYCHRON and AUHemolyzing ReagentRatio 1 to 100 dilutionPre-treatment - untilhemolysis is complete(approx. 1-2 minutes). | submissionsupportssubstantialequivalence ofthe calibratorsand newreagents.DifferentPerformancedata within thesubmissionsupportssubstantialequivalence. |
| Stability | Calibrator & Reagentunopened store at 2° to8°C until expiration dateCalibrator reconstituted =8 hours 15°- 25°C48 hours at 2°- 8°Cunless expiration date isexceededOpen hemoglobinreagent stable 60 days at2°-8°C unless exp. dateexceeded.Open A1c reagent stable30 days at 2°- 8°Cunless exp. dateexceeded. | Calibrator & Reagentunopened store at 2° to8°C until expiration dateCalibrator reconstituted =up to 8 hours at 15 -25°Cup to 30 hours at 2 - 8°Cup to 30 days at - 20 °C.Calibration Stability = 14daysReagent on-board = 30daysKit Shelf Life Stability =18 months at launch | DifferentStability datawithin thesubmissionsupports newclaims. |
| Reporting Units | SYNCHRON calculationsIFCC HbA1cconcentration in percent.Must use calculation inIFU that converts IFCC toNGSP. | % HbA1c (NGSP) andmmol/mol (IFCC) | DifferentIFCC /IUPACcommitteeupdated theirrecommend-ations on HbA1cunits andnomenclature in2007. |
| Sensitivity | Sensitivity is defined asthe lowest measurableconcentration which canbe distinguished from | THb:LoB = 0.05 mmol/L (0.09g/dL);LoD = 0.10 mmol/L (0.16g/dL) | DifferentSensitivity forthe new device |
| zero with 95%confidence.Sensitivity for the totalhemoglobindetermination is 6 g/dL.Sensitivity for the A1cdetermination 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 LoBand LoD, ratherthan general sensitivity.Performancedata within thesubmissionsupportssubstantialequivalence andnew claim. | |
| SpecimenStorage andStability | Whole blood samplesstable for:No longer than 7 days at2 - 8°C3 months at -15 C to -20°CHemolysate stable 4hours at roomtemperature and 24hours at 2° to 8°C | Samples (non-pretreated)are stable up to 8 hourswhen stored at 25°C,7 days when stored at2...8°C and up to 3months when frozen at -20°C. Whole bloodsamples are stable for 18months at -70°CHemolyzed (pre-treated)samples are stable up to4 hours when stored at15...25°C, up to 24 hourswhen stored at 2...8°C, ifstored in a sealedcontainer. | DifferentStability datawithin thesubmissionsupportssubstantialequivalence andnew claims. |
Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
Telephone: (714) 993-53321
Facsimile: (714) 961-4234
Internet: www.beckmancoulter.com
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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
・
,
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Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
.
.
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.
Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
Telephone: (714) 993-5321
Facsimile: (714) 961-4234
Internet: www.beckmancoulter.com
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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.
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Method Comparison Study Results
·
| Candidate | Slope | Intercept | R | N | PredicateMethod |
|---|---|---|---|---|---|
| AU HbA1c TestSystem | 0.901 | 0.3140 | 0.9941 | 130 | SYNCHRONSystemsHemoglobin A1c(HbA1c)Reagent |
AU HbA1c Test System Precision Study Results
| TYPE OFIMPRECISION | SAMPLE TYPE | No. ofDataPoints | Mean%HbA1c | CV% | SD(%HbA1c) |
|---|---|---|---|---|---|
| Within run | HemolysateControl Pool 1 | 80 | 5.3 | 1.44 | 0.08 |
| HemolysateControl Pool 2 | 80 | 7.4 | 1.03 | 0.08 | |
| HemolysateControl Pool 3 | 80 | 9.4 | 1.03 | 0.10 | |
| Total | HemolysateControl Pool 1 | 80 | 5.3 | 2.07 | 0.11 |
| HemolysateControl Pool 2 | 80 | 7.4 | 1.84 | 0.14 | |
| HemolysateControl 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
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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
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic 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
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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
§ 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).