(448 days)
ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific SelectralFlexor analyzers.It is not intended for use in Point of Care settings.
HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
ELITech Clinical Systems HbA1c CALIBRATOR SET is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
ELITech Clinical Systems HbA1c Control L+H is a quality control with.2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific SelectralFlexor analyzers as specified in the instructions for use.
The device for this submission is available as a kit only. It consists of 3 reagents. Reagent R1 contains suspended latex particles in a buffer with stabilizers and sodium azide. Reagent R2a and Reagent R2b are mixed to prepare a working reagent, Reagent 2. This mixture contains Mouse anti-human HbA1c monoclonal antibody and Goat anti-mouse IgG polyclonal antibody in a buffer containing stabilizers and sodium azide. Reagent R3, a hemolysis reagent, is an aqueous solution containing sodium azide.
The device for this submission is available as kit only. It consists of 4 different levels of calibrator at 0.5 mL volume. Each level consists of lyophilized hemolysates prepared from human erythrocytes. HbA1c CALIBRATOR SET is prepared exclusively from the blood of donors teste individually and found to be negative for HbsAg and to antibodies to HCV and HI according to FDA-approved methods.
ELITech Clinical Systems HbA1c Control L + H is a two level quality control products consisting of lyophilized hemolysates prepared from human erythrocytes containing constituents at desired levels. HbA1c CONTROL L+ H is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
The provided document is a 510(k) summary for the ELITech Clinical Systems HbA1c reagent, calibrator set, and control set. It details the substantial equivalence of these devices to a predicate device, focusing on their intended use, assay principle, composition, and performance characteristics. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for training/test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).
The document is a regulatory submission for in vitro diagnostic (IVD) assays, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., test set sample size, data provenance, expert-established ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, how training ground truth was established) are not applicable or typically reported in this type of submission. Performance for IVD devices is usually evaluated through analytical studies (precision, accuracy/method comparison, linearity, interference) rather than clinical studies with expert-adjudicated ground truth as seen in AI/ML device submissions.
Here's an attempt to answer based on the provided text, highlighting where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative table for accuracy. Instead, it compares the proposed device's performance to the predicate device's performance and clinical utility. The "Conclusion" sections uniformly state that the device "met all acceptance criteria" without detailing what those criteria were. However, we can infer some performance metrics:
| Performance Metric | Acceptance Criteria (Not explicitly stated, but implied by comparison/predicate) | Reported Device Performance (ELITech Clinical Systems HbA1c) |
|---|---|---|
| Measuring Range | Comparable to predicate (2 to 16 %) | 2.5 to 16 % |
| Limit of Blank (LoB) | Established and comparable to predicate | 0.6 % |
| Limit of Detection (LoD) | Established and comparable to predicate | 0.7 % |
| Within-Run Precision (CV) | Expected to be low and comparable to predicate for various HbA1c levels | Level 4.4 %: CV= 1.1 %Level 6.7 %: CV= 0.9 %Level 9.5 %: CV= 1.0 % |
| Total Precision (CV) | Expected to be low and comparable to predicate for various HbA1c levels | Level 4.4 %: CV= 2.3 %Level 6.7 %: CV= 1.9 %Level 9.5 %: CV= 2.9 % |
| Method Comparison (Correlation to Predicate) | Strong correlation (high 'r' value) and good agreement (slope close to 1, intercept close to 0) to predicate. | y = 0.926x + 0.1 %r = 0.984 |
| Interference | No significant interference from common interfering substances (bilirubin, triglycerides, Hb variants, etc.) | No significant interference reported for: Unconjugated bilirubin (up to 30 mg/dL), Conjugated bilirubin (up to 29.5 mg/dL), Triglycerides (up to 2000 mg/dL), Acetylsalicylic acid (up to 200 mg/dL), Rheumatoid factor (up to 1000 IU/mL), Ascorbic acid (up to 20 mg/dL), HbC, HbS, HbD, HbE, HbA2. High HbF leads to underestimation. No significant interference from carbamylated or acetylated hemoglobin, or labile HbA1c. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the method comparison (accuracy) study. It provides the regression equation and correlation coefficient (r = 0.984) derived from this study, but not the 'n' value.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). This type of detail is not typically included in a 510(k) summary for an IVD reagent. The study would have been an analytical validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For an IVD assay like HbA1c, "ground truth" for individual samples is typically established by comparative methods (e.g., a reference method like HPLC or a legally marketed predicate device) rather than expert adjudication. The study is a method comparison study against the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As this is an IVD assay comparison, not an AI/ML image-based diagnosis, expert adjudication methods are not used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML device, and no MRMC study or evaluation of human reader improvement is relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a quantitative diagnostic reagent kit for an automated analyzer. Its performance is inherently "standalone" in the sense that the instrument processes the sample and the reagent measures the HbA1c level without direct human interpretive intervention beyond running the assay and interpreting the numerical result. There is no "algorithm" in the AI/ML sense to be evaluated in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the method comparison study, the "ground truth" (or reference) for evaluation appears to be the predicate device (Pointe Scientific Hemoglobin A1c Reagent Set). The study compares the ELITech device's results (Y) against the predicate device's results (X) using regression analysis ($y=0.926x + 0.1 %$).
8. The sample size for the training set
- Not Applicable. This is an IVD diagnostic reagent, not an AI/ML algorithm that undergoes "training." The device's performance is characterized through analytical validation studies.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or establishment of ground truth for training in the context of this type of device.
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Section 5 : 510(k) Summary
MAY 19 2011
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
The assigned 510(k) number is : K100547
| Submitter | SEPPIM S.A.S. |
|---|---|
| Address | Zone Industrielle, 61500 SEES, FRANCE |
| Phone number | + 33 (0)2 33 81 21 00 |
| Fax number | + 33 (0)2 33 28 77 51 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) |
| Date of Preparation | February 8th, 2010 |
Device names
| REAGENT : | |
|---|---|
| Trade/proprietary Name: | ELITech Clinical Systems HbA1c |
| Common or Usual Name: | Glycosylated Hemoglobin "HbA1c" |
| Device Class | Class II |
| Classification name | Assay, Glycosylated Hemoglobin (Sec.864.7470) |
| Product code | LCP; Assay, Glycosylated Hemoglobin |
| Predicate device | Hemoglobin A1c Reagent Set (K031539) |
|---|---|
| ------------------ | -------------------------------------- |
| Device description | The device for this submission is available as a kit only. It consists of 3 reagents. Reagent R1 contains suspended latex particles in a buffer with stabilizers and sodium azide. Reagent R2a and Reagent R2b are mixed to prepare a working reagent, Reagent 2. This mixture contains Mouse anti-human HbA1c monoclonal antibody and Goat anti-mouse IgG polyclonal antibody in a buffer containing stabilizers and sodium azide. Reagent R3, a hemolysis reagent, is an aqueous solution containing sodium azide. |
|---|---|
| -------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Intended Use | ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. |
|---|---|
| -------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Indication for use | HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients. |
|---|---|
| -------------------- | --------------------------------------------------------------------------------------------------------- |
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Comparison to Predicate device
| ELITech Clinical Systems | Predicate device | ||
|---|---|---|---|
| Device (HbA1c) | (Pointe Scientific HemoglobinA1c Reagent Set) | ||
| Intended use | ELITech Clinical SystemsHbA1c is intended for use in thequantitative in vitro diagnosticdetermination of hemoglobinA1c (HbA1c) in human wholeblood on Vital ScientificSelectra/Flexor analyzers. It isnot intended for use in Point ofCare settings. | For the quantitative determinationof hemoglobin A1c (HbA1c) inhuman blood. For in vitrodiagnostic use only. | |
| Indication for Use | HbA1c measurements are usedfor the monitoring of long termblood glucose control in diabeticpatients. | The determination of hemoglobinA1c is most commonly performedfor the evaluation of glycemiccontrol in diabetes. HemoglobinA1c values provide an indicationof glucose levels over thepreceding 4-8 weeks. A higherhemoglobin A1c value indicatespoorer glycemic control. | |
| Assay protocol | Immuno-turbidimetry enhancedby latex particles using a two-reagent reaction sequence. | Same. | |
| Composition | Reagent R1 :Suspended latex particles 0.13%;Buffer, stabilizers ; sodium azide <0.1% | Reagent R1 :Latex particles (uncoated) 0.13%;Buffer, stabilizers ; sodium azide< 0.1% | |
| Working Reagent R2 (R2a+R2b):Mouse anti-human HbA1cmonoclonal antibody 0.05 mg/mL;Goat anti-mouse IgG polyclonalantibody 0.08 mg/dL; Buffer,stabilizers ; sodium azide < 0.1% | Reagent R2 (when combined):Mouse anti-human HbA1cmonoclonal antibody 0.05 mg/mL;Goat anti-mouse IgG polyclonalantibody 0.08 mg/dL; Buffer,stabilizers ; sodium azide < 0.1% | ||
| Reagent R3 (Hemolysis reagent)Aqueous solution; sodium azide< 0.1 % | Hemolysis reagentWater and stabilizer. | ||
| Appearance of reagents | Liquid form.Reagents R1 and R3 are ready touse.Reagent R2 is a working reagent thatmust be prepared by mixing thecontent of Reagent R2b in the vialR2a. | Reagent R1 and hemolysis reagentare supplied as ready to use liquids.Reagent R2 is prepared by pouringthe entire contents of the R2b vialinto the R2a vial. | |
| Traceability/Standardization | Values are defined in thereference NGSP values andtraceable to the IFCC referencemethod. | Against IFCC and NGSPtraceable reference materials | |
| Sample type | Whole blood collected on EDTA | Venous blood with EDTA | |
| Reagent storage | To store at 2-8 °C and protectedfrom light. The reagents are | To store at 2-8°C. The reagentsare stable until the expiry date | |
| stable until the expiry date statedon the label | stated on the label | ||
| Expected values | Non-diabetics : 4.0 -6.0 % | < 6 % for a non-diabetics< 7 % for glycemic control of aperson with diabetes. | |
| Instrument | SELECTRA JUNIOR | Pointe Scientific Hitachiinstruments (model 717 or 917) | |
| Measuring range | 2.5 to 16 % | 2 to 16 % | |
| Limit of Blank (LoB) | 0.6 % | ||
| Limit of Detection (LoD) | 0.7% | ||
| Precision | Within runLevel 4.4 %CV= 1.1 %Level 6.7 %CV= 0.9 %Level 9.5 %CV= 1.0 % | Within runLevel 5.48 %CV= 1.43 %Level 10.28 % CV= 1.72 % | |
| TotalLevel 4.4 %CV= 2.3 %Level 6.7 %CV= 1.9 %Level 9.5 %CV= 2.9 % | Day to DayLevel 5.48 %CV= 2.77 %Level 10.28 % CV= 2.68 % | ||
| Method comparison | $y=0.926x + 0.1 %$$r= 0.984$ | $y=1.050x - 0.481 %$$r= 0.988$ | |
| Limitations | No significant interference for thefollowing components: | No significant interference for thefollowing components | |
| - Unconjugated bilirubin (up to30 mg/dL)- Conjugated bilirubin (up to29.5 mg/dL)- Triglycerides (up to 2000mg/dL)- Acetylsalicylic acid (up to 200mg/dL) | Bilirubin to 50 mg/dLTriglycerides to 2000 mg/dLCarbamylated hemoglobin to7.5 mmol/LAcetylated hemoglobin to 5.0mmol/LHemoglobin variants : HbA2,HbC, HbS, HbE | ||
| - Rhumatoid factor (up to 1000IU/mL)- Ascorbic acid (up to 20 mg/dL)- Interference due to Vitamin Ehas not been assessed. | Elevated levels of HbF may leadto an underestimation of HbA1c. | ||
| Hemoglobin variants:- HbC, HbS, HbD, HbE andHbA2: No significantinterference.- High concentration of HbFlead to a underestimation ofHbA1c. | |||
| Chemically modified Hemoglobin:- Carbamylated hemoglobin:No significant interference up to10 mmol/L of added sodiumcyanate.- Acetylated hemoglobin: Nosignificant interference up to 10 |
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| mmol/L of added aspirin.- Labile HbA1c: No significantinterference up to 1000 mg/dL ofadded glucose.- It has been reported that resultsmav be unreliable with patientswho suffer from alcoholism(formation of acetaldehydehemoqlobin) | |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
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.
the instructions for use.
| Conclusion | The performance data and other information conclude that the safety andeffectiveness of the device is not compromised, and that it met all acceptancecriteria, demonstrating that the device is substantially equivalent to its respectivepredicate device. |
|---|---|
| Device names | |
| CALIBRATOR :Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems HbA1c Calibrator SetCalibrator for Glycosylated Hemoglobin , "HbA1c Calibrator Set"Class IICalibrator for Hemoglobin or Hematocrit measurement (21 CFRSec.864.8165)JIT - Calibrator for Glycosylated Hemoglobin |
| Predicate device | Hemoglobin A1c calibrator Set (K031539) |
| Device description | The device for this submission is available as kit only. It consists of 4 differentlevels of calibrator at 0.5 mL volume.Each level consists of lyophilized hemolysates prepared from human erythrocytes.HbA1c CALIBRATOR SET is prepared exclusively from the blood of donors testeindividually and found to be negative for HbsAg and to antibodies to HCV and HIaccording to FDA-approved methods. |
| Intended Use | ELITech Clinical Systems HbA1c CALIBRATOR SET is a calibrator with 4 differerlevels of values for in vitro diagnostic use in the calibration of quantitative ELITecClinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified i |
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Comparison to Predicate device
| ELITech Clinical Systems Device(HbA1c CALIBRATOR SET) | Predicate Device(Pointe Scientific Hemoglobin A1c Calibrator Set) | |
|---|---|---|
| Intended use | ELITech Clinical Systems HbA1c CALIBRATOR SET is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use. | For the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. |
| Format | Lyophilized hemolysates from human erythrocytes. | Hemolysate prepared from packed human erythrocytes. |
| Levels | Four (4) levels | Four (4) levels |
| Handling | Reconstitute each calibrator using 0.5 mL of deionized water. Gently mix for 10 minutes or until all material has dissolved. Each Control should be hemolysis before use | Same |
| Stability | Prior to reconstitution : To store at 2-8 °C and protected from light until the expiry dateAfter reconstitution : Calibrators are stable 30 days when stored at 2-8 °C - After opening, the vials should be kept correctly and tightly capped to prevent contamination and evaporation | Same |
Conclusion The performance data and other information conclude that the safety and effectiveness of the device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to his respective predicate device:
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.
| Device names | |
|---|---|
| CONTROLS:Trade/proprietary Name:Common or Usual Name: | ELITech Clinical Systems HbA1c CONTROL L + HSingle (Specified) analyte control, Assayed, "HbA1c CONTROL L + H" |
| Device Class | Class I |
| Classification name | Quality control material (assayed and unassayed). (Sec.862.1660) |
| Product code | JJX- Single (specified) analyte controls (assayed and unassayed) |
| Predicate device | Hemoglobin A1c Control Set (K031539) |
| Device description | ELITech Clinical Systems HbA1c Control L + H is a two level quality control productsconsisting of lyophilized hemolysates prepared from human erythrocytes containingconstituents at desired levels.HbA1c CONTROL L+ H is prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV and HIVaccording to FDA-approved methods. |
- ELITech Clinical Systems HbA1c CONTROL L+ H is a quality control with 2 levels of Intended Use values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
Comparison to Predicate device
| ELITech Clinical Systems Device(HbA1c CONTROL L+H) | Predicate Device(Pointe Scientific Hemoglobin A1cControl Set) | |
|---|---|---|
| Intended use | ELITech Clinical Systems HbA1cCONTROL L+ H is a quality control with 2levels of values (Low and High values) forin vitro diagnostic use in accuracy controlof quantitative ELITech Clinical SystemsHbA1c on Vital Scientific Selectra/Flexor | For the purpose of monitoringaccuracy and precision in thequantitative determination of humanhemoglobin A1c (HbA1c) in bloodby automated immunoassay. For invitro diagnostic use only. |
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| ELITech Clinical Systems Device(HbA1c CONTROL L+H ) | Predicate Device(Pointe Scientific Hemoglobin A1cControl Set) | |
|---|---|---|
| analyzers as specified in the instructionsfor use. | ||
| Format | Lyophilized hemolysates from humanerythrocytes. | Hemolysate prepared from packedhuman erythrocytes. |
| Levels | Two (2) levels | Two (2) levels |
| Handling | Reconstitute each control using 0.5 mL ofdeionized water, Gently mix for 10minutes or until all material has dissolved.Each Control should be hemolysis beforeuse | Same |
| Stability | Prior to reconstitution : To store at 2-8 °Cand protected from light until the expirydate | Same |
| After reconstitution : Controls are stable30 days when stored at 2-8 °C- After opening, the vials should be keptcorrectly and tightly capped to preventcontamination and evaporation |
Conclusion The performance data and other information conclude that the safety and effectiveness of the device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to his respective predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/8/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper half of the circle.
SEPPIM S.A.S c/o Debra Hutson ELITechGroup Epoch Biosciences 21720 23rd Dr. SE. Suite 150 Bothell, Washington 98021
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/8/Picture/5 description: The image shows the date May 19, 2011. The month is written in all caps. The day is written as a single digit. The year is written as four digits.
Re: K100547
Trade Name: ELITech Clinical Systems HbA1c Reagent, ELITech Clinical Systems HbA1c Calibrator Set, ELITech Clinical Systems HbA1c Control L+H Regulation Number: 21CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Codes: LCP, JIT, JJX Dated: April 18, 2011 Received: April 19, 2011
Dear Ms Hutson:
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).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
G.C.
Courtney 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
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Indications for Use Form
510(k) Number (if known): K100547
Device Name: ELITech Clinical Systems HbA1c
Indications for Use:
ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific SelectralFlexor analyzers.It is not intended for use in Point of Care settings.
HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100547
Page 1 of 3
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Indications for Use Form
510(k) Number (if known): j/100547
Device Name: ELITech Clinical Systems HbA1c calibrator set
Indications for Use:
ELITech Clinical Systems HbA1c Calibrator set is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K10054
Page 2 of 3
{12}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K100547
Device Name: ELITech Clinical Systems HbA1c Control L+ H
Indications for Use:
ELITech Clinical Systems HbA1c Control L+H is a quality control with.2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific SelectralFlexor analyzers as specified in the instructions for use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) `1<10054
Page 3 of 3
§ 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).