(75 days)
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods. For in vitro diagnostic use. The measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Each Hemoglobin Capillary Collection System (HCCS) contains a combination of the following components (quantity is dependent upon kit size): 1. Sample Preparation Vials: clear microvials with blue pierceable caps, each contains 1.5 mL of the HCCS reagent. 2. Capillaries: plastic capillaries (5 uL) in a dispenser. 3. Capillary Holder: holder for manipulating the capillaries. 4. Labels: to label prepared samples. The HCCS provides the necessary materials for a professional user to collect and prepare whole blood samples (capillary or venous blood) for analysis with the VARIANT™ II Hemoglobin A1c Program run on the VARIANT™ II Hemoglobin Testing System or the D-10™ Hemoglobin A1c Program run on the D-10™ Hemoglobin Testing System.
Acceptance Criteria and Study Summary for Hemoglobin Capillary Collection System (HCCS)
This document summarizes the acceptance criteria and the study that demonstrates the Bio-Rad Laboratories, Inc. Hemoglobin Capillary Collection System (HCCS) meets these criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a method comparison study to establish substantial equivalence rather than explicit quantitative acceptance criteria with predefined thresholds. The acceptance criterion implicitly sought was no significant difference between HCCS capillary samples and traditional venous EDTA samples when analyzed by the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (from Method Comparison Studies) |
|---|---|
| No significant difference in hemoglobin A1c values between capillary samples collected with HCCS and venous whole blood samples. | HCCS Comparison Study on the VARIANT™ II Hemoglobin A1c Program:- Sample Value Range: 4.2% HbAlc to 12.6% HbAlc- The specific performance metrics (e.g., correlation coefficient, bias) are not fully legible in the provided table but the conclusion states "no significant difference". |
| HCCS Comparison Study on the D-10™ Hemoglobin A1c Program:- Sample Value Range: 4.2% HbAlc to 14.3% HbAlc- The specific performance metrics (e.g., correlation coefficient, bias) are not fully legible in the provided table but the conclusion states "no significant difference". |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The exact number of patients included in each method comparison study (VARIANT™ II and D-10™) is not explicitly stated. The text only mentions that "One HCCS capillary sample and one venous EDTA primary tube sample were collected from each patient."
- Data Provenance: The study was conducted at an external site, implying data was collected from a clinical setting. The country of origin is not specified but given the submitter's location (Hercules, California, USA) and the FDA submission, it is likely the US. The study appears to be prospective, as it involved collecting samples specifically for the comparison.
3. Number of Experts and Qualifications for Establishing Ground Truth (Test Set)
This study does not involve expert readers or a ground truth established by experts in the traditional sense of image interpretation or diagnostic decision-making. The ground truth for hemoglobin A1c values is established by the predicate HPLC methods (VARIANT™ II and D-10™ Hemoglobin A1c Programs) using venous blood samples, which are the established and legally marketed methods for this measurement.
4. Adjudication Method (Test Set)
Not applicable. This was a method comparison study for quantitative measurement, not a study requiring adjudication of expert interpretations. The "ground truth" was derived from the reference methods (predicate HPLC systems).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This study evaluates a sample collection system for a quantitative analyte (HbA1c), not an imaging or diagnostic interpretation device requiring human reader assessment or AI assistance.
6. Standalone Performance
Yes, a standalone performance was done in the sense that the HCCS was evaluated with the predicate devices. The "performance evaluation studies" mentioned in the conclusion, along with the method comparison, assess the HCCS's ability to provide samples that yield comparable HbA1c results to the established venous collection methods when processed by the predicate instruments. The HCCS itself is a collection system, and its standalone performance is intrinsically tied to the accuracy of the HbA1c measurement obtained from samples collected with it.
7. Type of Ground Truth Used
The ground truth used was comparative analytical results from legally marketed and established predicate devices (VARIANT™ II Hemoglobin A1c Program and D-10™ Hemoglobin A1c Program) performing HbA1c measurements on venous whole blood samples. This serves as the reference standard against which the HCCS collected capillary samples are compared.
8. Sample Size for the Training Set
The document does not mention a training set as this device is not an AI/ML algorithm that requires training. It is a medical device for sample collection.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Summary of Safety and Effectiveness ... ...
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Submitter:
Bio-Rad Laboratories, Inc., Clinical Systems Division, 4000 Alfred Nobel Drive, Hercules. California 94547
Phone: (510) 741-6114; Fax: (510) 741-3954
Contact Person:
Jolene Bartilson, Regulatory Affairs Representative
Device Name:
Hemoglobin Capillary Collection System (HCCS)
Classification Name:
Blood specimen collection device, JKA
Assay, Glycosylated hemoglobin, LCP
Predicate Devices:
VARIANT™ II Hemoglobin A1c Program, Bio-Rad Laboratories, Inc., K070452 -Wash/Diluent Solution
D-10TM Hemoglobin A1c Program, Bio-Rad Laboratories, Inc., K031043 - Wash/Diluent Solution
Intended Use:
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods.
For in vitro diagnostic use.
Indications For Use:
The measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
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Description of the Device:
Each Hemoglobin Capillary Collection System (HCCS) contains a combination of the following components (quantity is dependent upon kit size):
-
Sample Preparation Vials: clear microvials with blue pierceable caps, each contains 1.5 mL of the HCCS reagent.
-
Capillaries: plastic capillaries (5 uL) in a dispenser.
-
Capillary Holder: holder for manipulating the capillaries.
-
Labels: to label prepared samples.
The HCCS provides the necessary materials for a professional user to collect and prepare whole blood samples (capillary or venous blood) for analysis with the VARIANT™ II Hemoglobin A1c Program run on the VARIANT™ II Hemoglobin Testing System or the D-10™ Hemoglobin A1c Program run on the D-10™ Hemoglobin Testing System.
Technical Characteristics Compared to the Predicates:
The Hemoglobin Capillary Collection System (HCCS) reagent is intended to dilute whole blood samples in the same way that the predicate Wash/Diluent Solutions of the VARIANT™ II Hemoglobin A1c Program and D-10™ Hemoglobin A1c Program are used to dilute whole blood samples; in preparation for the percent determination of hemoglobin A I c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The similarities and differences between the HCCS and the predicates are summarized in the following table:
| Characteristic | New Device:HemoglobinCapillaryCollection System(HCCS) | Predicate Device:VARIANT™ IIHbA1c Program,Wash/Diluent Solution(K070452) | Predicate Device: D-10™ HbA1cProgram,Wash/DiluentSolution (K031043) |
|---|---|---|---|
| Intended Use | The HemoglobinCapillaryCollection System(HCCS) is intendedfor the collection ofhuman whole bloodfor the percentdetermination ofhemoglobin A1cusing Bio-RadHPLC methods. For | The Bio-RadVARIANT IIHemoglobin A1cProgram is intended forthe percentdetermination ofhemoglobin A1c inhuman whole bloodusing ion-exchangehigh performance liquidchromatography | The Bio-Rad D-10Hemoglobin A1cProgram is intended forthe percentdetermination ofhemoglobin A1c inhuman whole bloodusing ion-exchangehigh-performanceliquid chromatography(HPLC). The Bio-Rad |
| in vitro diagnosticuse. | (HPLC). The Bio-RadVARIANT IIHemoglobin A1cProgram is intended forProfessional Use Only. | D-10 Hemoglobin A1cProgram is intended forProfessional Use Only. | |
| IndicationsFor Use | Measurement ofpercent hemoglobinA1c is effective inmonitoring long-term glucosecontrol inindividuals withdiabetes mellitus. | Measurement ofpercent hemoglobinA1c is effective inmonitoring long-termglucose control inindividuals withdiabetes mellitus. | Measurement ofpercent hemoglobinA1c is effective inmonitoring long-termglucose control inindividuals withdiabetes mellitus. |
| Formulation | Aqueous solutionof EDTA andpotassium cyanide. | Deionized water with<0.05% sodium azideas a preservative. | Deionized water with<0.05% sodium azideas a preservative. |
| Sample Type | Capillary orvenous blood fromplastic capillary. | Venous whole bloodsample collected in anEDTA vacuumcollection tube. | Venous whole bloodsample collected in anEDTA vacuumcollection tube. |
| Purpose ofReagent | Sample dilution forhemoglobin A1canalysis using Bio-Rad HPLCmethods. | Sample dilution forhemoglobin A1canalysis using Bio-RadHPLC method. | Sample dilution forhemoglobin A1canalysis using Bio-RadHPLC method. |
| Timing ofDilution Step | Sample dilution attime of samplecollection. Nofurther preparationis required; theVARIANT IIHemoglobinTesting System andD-10 HemoglobinTesting System donot performdilution on sampleswithdrawn fromsample vials. | Dilution with theWash/Diluent Solutionis performedautomatically by theVARIANT IIHemoglobin TestingSystem at time ofanalysis; when vacuumcollection tubes areused. | Dilution with theWash/Diluent Solutionis performedautomatically by the D-10 Hemoglobin TestingSystem at time ofanalysis; when vacuumcollection tubes areused. |
| Stability ofSample | Prepared samplescan be passed onfor analysis orshipped to another | Whole bloodspecimens may bestored up to 7 days at 2to 8 °C. | Whole bloodspecimens may bestored up to 7 days at 2to 8 °C or 3 days at |
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:
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:
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| location. Samplesare stable for: 4days at 42 °C, 2weeks at 15 to 30°C, or 4 weeks at 2to 8 °C. | room temperature (15to 30 °C). |
|---|---|
| -------------------------------------------------------------------------------------------------------------------- | ------------------------------------ |
Testing to Establish Substantial Equivalence:
Method Comparison:
A method comparison study was conducted at an external site to determine if there is a significant difference in the hemoglobin A1c values of capillary samples collected and prepared with the Hemoglobin Capillary Collection System (HCCS) versus the values obtained from the corresponding venous whole blood samples when analyzed with the VARIANT™ II Hemoglobin A1c Program on the VARIANT™ II Hemoglobin Testing System and with the D-10™ Hemoglobin A1c Program on the D-10™ Hemoglobin Testing System. One HCCS capillary sample and one venous EDTA primary tube sample were collected from each patient; the samples were then analyzed with the VARIANT™ II Hemoglobin A1c Program or the D-10TM Hemoglobin A1c Program. The results of the study are summarized in the tables below:
HCCS Comparison Study on the VARIANT™ II Hemoglobin A1c Program
| · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·M. A . A | |||||
|---|---|---|---|---|---|
| Method | nle Value Kange | SIDDE | Intercent | ||
| : VII HhAlc Program | 126%HhAlcy to |
HCCS Comparison Study on the D-10™ Hemoglobin A1c Program
| ということです。 そして、 そして、 その他の人気をしている。 この時には、 2005年には、 2005年には、 2005年には、 2005年に、 2005年に、 2005年に、 2005年に、 2005年にMethod | ample Value Kange | ntercen | |
|---|---|---|---|
| : D-10 HbAlc Programand an any and sells and address and | x to 14.3 %HbAIc | -0.06X |
Conclusion:
The results of the method comparison study and performance evaluation studies of the Hemoglobin Capillary Collection System (HCCS) show that there is no significant difference in the hemoglobin Alc values for whole blood samples prepared with the HCCS versus whole blood samples diluted with the predicate Wash/Diluent Solutions of the VARIANT II Hemoglobin A1c Program and D-10 Hemoglobin A1c Program. Therefore, we trust that the information provided in this 510(k) Submission will support a decision of substantial equivalence of the Hemoglobin Capillary Collection System (HCCS).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bio-Rad Laboratories, Inc c/o Ms. Jolene Bartilson 4000 Alfred Nobel Dr Hercules, CA 94547
JUN - 8 2009
K090737 Re:
Trade/Device Name: Hemoglobin Capillary Collection System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP and JKA Dated: March 19, 2009 Received: March 20, 2009
Dear Ms. Bartilson:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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Page - 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
KO9073 510(k) Number (if known):
Device Name: Hemoglobin Capillary Collection System (HCCS)
Indication For Use:
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods.
For in vitro diagnostic use.
The measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090737
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§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.