(30 days)
The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.
The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and the Hemocue® measurement system. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.
Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.
For In Vitro Diagnostic Use Only
The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoglobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).
Here's an analysis of the acceptance criteria and study details for the HemoPoint® H2 Hemoglobin Measurement System based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for HemoPoint® H2 Hemoglobin Measurement System
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical targets for all parameters. However, it presents "Comparison to Predicate Device" that implies the acceptance criteria are met if the device's performance is "equivalent" to the predicate or within acceptable clinical ranges. For precision and correlation, specific numerical results are provided.
| Metric / Parameter | Acceptance Criteria (Implied by Predicate Comparison or Performance Goal) | Reported HemoPoint® H2 Device Performance (HemoPoint® H2 cuvette measured in HemoPoint® H2 device) | Reported HemoPoint® H2 Device Performance (HemoPoint® H2 cuvette measured in HemoCue device) |
|---|---|---|---|
| Precision (Within-run imprecision) | ≤ 2% (overall stated goal) | ||
| Hemoglobin/high (15.7 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.087 g/dL, CV 0.5% | Swr 0.102 g/dL, CV 0.7% |
| Hemoglobin/low (11.8 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.070 g/dL, CV 0.6% | Swr 0.105 g/dL, CV 0.9% |
| Hemoglobin/normal (8.0 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.058 g/dL, CV 0.7% | Swr 0.068 g/dL, CV 0.8% |
| Precision (Total Precision) | (Not explicitly stated as a target, but compared) | ||
| Hemoglobin/high (15.7 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.1747 g/dL, CV 1.1% | ST 0.302 g/dL, CV 1.9% |
| Hemoglobin/low (11.8 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.162 g/dL, CV 1.4% | ST 0.198 g/dL, CV 1.6% |
| Hemoglobin/normal (8.0 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.122 g/dL, CV 1.5% | ST 0.158 g/dL, CV 1.9% |
| Correlation Coefficient (vs. NCCLS H15-A3 reference) | ≥ 0.998 (for comparison to predicate) or high correlation for self-system | 0.999 (R=0.999) | Not applicable (this comparison is for HemoPoint H2 system vs. reference) |
| Correlation Coefficient (vs. HemoCue System) | > 0.995 (for HemoPoint® H2 cuvettes on HemoCue) | 0.995 (R=0.995) (for HemoPoint® H2 system vs. HemoCue) | 0.997 (R=0.997) (for HemoPoint® H2 cuvettes in HemoCue device vs. HemoCue) |
| Measurement range | 0 - 25.6 g/dL (Equivalent to predicate) | 0 - 25.6 g/dL | Equivalent (same as HemoPoint H2 self-system) |
| Specified accuracy | ± 0.3 g/dL at ≈ 14 g/dL (Equivalent to predicate) | ± 0.3 g/dL at ≈ 14 g/dL | Equivalent (same as HemoPoint H2 self-system) |
| Sample material | venous, arterial or capillary human blood (Equivalent to predicate) | venous, arterial or capillary human blood | Equivalent (same as HemoPoint H2 self-system) |
| Measuring time | Approximately 30 - 60 sec (Equivalent to predicate) | Approximately 30 - 60 sec | Equivalent (same as HemoPoint H2 self-system) |
| Measuring units | mol/L, g/dL, g/L (Equivalent to predicate) | mol/L, g/dL, g/L | Equivalent (same as HemoPoint H2 self-system) |
| Calibration | against NCCLS reference method (Equivalent to predicate) | against NCCLS reference method | Equivalent (same as HemoPoint H2 self-system) |
| Method | Azidemethemoglobin method (Vanzetti) (Equivalent to predicate) | Azidemethemoglobin method (Vanzetti) | Equivalent (same as HemoPoint H2 self-system) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test set sample size: For the correlation studies, the sample size was N=100 duplicate measurements for each comparison (HemoPoint H2 vs. NCCLS H15-A3, HemoPoint H2 vs. HemoCue, HemoPoint H2 cuvettes in HemoCue vs. HemoCue).
- Data provenance: The blood samples used were stated as venous blood. The country of origin is not specified in the provided summary, but the manufacturer is Stanbio Laboratory, located in Boerne, Texas, USA. The studies appear to be prospective as they are reported as experimental data for a device seeking 510(k) clearance, implying new testing was performed to support the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is an automated hemoglobin measurement system. The "ground truth" is established through a recognized reference method (NCCLS H15-A3 standard) or comparison to an established predicate device (HemoCue System), rather than requiring expert qualitative assessment or interpretation.
4. Adjudication Method for the Test Set:
- None. As an automated quantitative measurement device, there is no need for an adjudication method in the context of expert review. The method for determining the reference values is through the specified chemical or instrumental reference methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically performed for devices that involve human interpretation, such as imaging systems or diagnostic aids. The HemoPoint® H2 is an automated quantitative measurement device and does not involve human interpretation of results that would necessitate an MRMC study.
6. Standalone Performance (Algorithm only without human-in-the-loop performance):
- Yes. The reported "Experimental Data" and "Precision" data represent the standalone performance of the device. The device provides a direct numerical output for hemoglobin concentration without requiring human intervention for interpretation beyond operating the instrument and collecting the sample. The comparisons are made against established reference methods or other automated devices.
7. Type of Ground Truth Used:
- The primary ground truth used is a reference method: NCCLS H15-A3. This is a recognized standard for total hemoglobin determination (cyanmethemoglobin method).
- Additionally, the device's performance (specifically the HemoPoint® H2 cuvettes) was compared against the HemoCue System, which serves as a predicate device and an established clinical standard for point-of-care hemoglobin measurement.
8. Sample Size for the Training Set:
- Not specified. The document does not provide details on a separate "training set" or how the device's algorithms (e.g., for calculating Hb from light absorbance) were developed or calibrated. The provided data focuses on validation and comparison to established methods. Automated systems like this are typically calibrated against known standards during manufacturing and do not usually have a "training set" in the machine learning sense that would be described in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not specified. As mentioned above, a "training set" in the typical machine learning context is not detailed. The ground truth for calibration would generally be established using internationally recognized hemoglobin standards and the NCCLS H15-A3 reference method, but this process is part of the device's design and manufacturing standards rather than a specific "training set" described in this summary. The device's calibration itself is stated to be "against NCCLS reference method."
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JUL 1 8 2008
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
(As required by 21 CFR 807.92)
| Trade Name: | HemoPoint® H2 Hemoglobin Measurement System | ||
|---|---|---|---|
| Common/Classification Name: | Automated Hemoglobin System | ||
| Device Classification: | Class: IICFR: 21 CFR 864.5620Product Code: GKR | ||
| Manufacturer: | Stanbio Laboratory1261 North Main StreetBoerne, Texas 78006 |
Device Description / Procedure Principle:
The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes.
The recognized reference method for tHb determination (tHb = total hemoglobin) is the cvanmethemoqlobin method, which is also known as the cyanhemoglobin method. The blood sample is diluted 1:251 with a reagent buffering solution. Here the erythrocytes are hemolysed and the bivalent iron in oxy- and desoxyhemoglobin are oxidised by the reagent potassium hexacyanoferrate (III) to trivalent iron and so converted to methemoglobin. Together with cyanide ions, which are also contained in the reagents, the methemoglobin forms a stable, colored complex, namely cyanmethemoglobin. This has a wide absorption maximum at 540 nm. This absorption is proportional to the tHb concentration.
In 1966, Vanzetti suggested to replace KCN by NaNg and thus was able to reduce the toxicity of the reagent mixture considerably.
Vanzetti's method is also known as the azide methemogobin method. A modified azide methemoglobin method is used in the HemoPoint® H2 system.
In the HemoPoint® H2, however, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed.
In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured.
Image /page/0/Picture/12 description: The image shows a diagram of an absorbing solution with concentration c. The diagram shows a light beam with initial intensity P0 passing through the absorbing solution of thickness b. The light beam exits the solution with a reduced intensity P. The diagram illustrates the concept of light absorption by a solution.
Principle of photometric transmitted light measurement.
P .: 100 % - light intensity, P: remaining light intensity, b: distance through the solution
For this purpose, light is directed through the blood sample and the transmission T is measured. From the amount of light absorbed by the sample, the concentration of the hemoglobin in the cuvette can be calculated using Lambert-Beers Law.
Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CONT'D
Intended Use:
The HemoPoint H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.
The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste
Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/L or 12.0 to 18.0 g/dL). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values and will not be reported.
For In Vitro Diagnostic Use Only
Comparison To Predicate Device: Precision:
Within-run imprecision HemoPoint® H2 System and HemoPoint® H2 Cuvettes on HemoCue Device ≤ 2%
| HemoPoint® H2 cuvette measuredin HemoPoint® H2 device | HemoPoint® H2measured in HemoCuedevice | |
|---|---|---|
| Hemoglobin/high(15.7 g/dL): | Swr 0.087 g/dL, CV 0.5% | Swr 0.102 g/dL, CV 0.7% |
| Within-Run Precision(NCCLS EP5-A): | ||
| Total Precision(NCCLS EP5-A): | ST 0.1747 g/dL, CV 1.1% | ST 0.302 g/dL, CV 1.9% |
| Hemoglobin/low(11.8 g/dL) | Swr 0.070 g/dL, CV 0.6% | Swr 0.105 g/dL, CV 0.9% |
| Within-Run Precision(NCCLS EP5-A): | ||
| Total Precision(NCCLS EP5-A): | ST 0.162 g/dL, CV 1.4% | ST 0.198 g/dL, CV 1.6% |
| Hemoglobin/normal(8.0 g/dL) | Swr 0.058 g/dL, CV 0.7% | Swr 0.068 g/dL, CV 0.8% |
| Within-Run Precision(NCCLS EP5-A): | ||
| Total Precision(NCCLS EP5-A): | ST 0.122 g/dL, CV 1.5% | ST 0.158 g/dL, CV 1.9% |
| Between-DayImprecisionSingle observation,20 days | 15.7 g/dL: SD 0.179 g/dL, CV 1.1%11.8 g/dL: SD 0.176 g/dL, CV 1.5%8.0 g/dL: SD 0.111 g/dL, CV 1.4% | 15.7 g/dL: SD 0.286 g/dL, CV 1.8%11.8 g/dL: SD 0.201 g/dL, CV 1.6%8.0 g/dL: SD 0.118 g/dL, CV 1.5% |
Correlation Study:
Correlation coefficient HemoPoint® H2 System compared to NCCLS H15-A3 reference method, venous blood: 2 0.998
Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: > 0.995
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CONT'D
Experimental Data:
HemoPoint® H2 System: (HemoPoint® H2 cuvettes measured in HemoPoint® H2 device):
| Regression line and correlationcoefficients compared to NCCLS H15-A3reference method (g/dL), venous blood(Summary of results) | - Y= 0.2929 + 1.0086X- R=0.999- N=100, duplicate measurements |
|---|---|
| Regression line and correlationcoefficients compared to HemoCuesystem (g/dL), venous blood,(Summary of results) | - Y= -5.8261 +1.0462X- R=0.995- N=100, duplicate measurements |
HemoPoint® H2 cuvettes measured in HemoCue device':
| Regression line and correlationcoefficients compared to HemoCuesystem (g/dL), venous blood,(Summary of results) | - Y=-0.2181 + 1.0159X- R=0.997- N=100, duplicate measurements |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------- |
Comparison to Predicate Device:
| Specification | HemoPoint® H2 (current cuvette) | HemoPoint® H2 (modified cuvette) | Comments |
|---|---|---|---|
| Measurement range | 0 - 25.6 g/dL | 0 - 25.6 g/dL | equivalent |
| Specified range | 0 - 25.6 g/dL | 0 - 25.6 g/dL | equivalent |
| Specified accuracy | $\pm$ 0.3 g/dL at $\approx$ 14 g/dL | $\pm$ 0.3 g/dL at $\approx$ 14 g/dL | equivalent |
| Sample material | venous, arterial orcapillary human blood | venous, arterial orcapillary human blood | equivalent |
| Measuring time | Approximately30 - 60 sec | Approximately30 - 60 sec | equivalent |
| Measuring units | mol/L, g/dL, g/L | mol/L, g/dL, g/L | equivalent |
| Calibration | against NCCLS referencemethod | against NCCLS referencemethod | equivalent |
| Method | Azidemethemoglobinmethod (Vanzetti) | Azidemethemoglobinmethod (Vanzetti) | equivalent |
Conclusion / Substantial Equivalence:
The modified HemoPoint® H2 cuvettes for the HemoPoint® H2 Hemoglobin Photometer and and the predicate devices, Hemo Point® H2 Hemoglobin Measurement System with microcuvette are substantially equivalent based on design and function.
Kirk Johnson QA/Regulatory Affairs Manager Stanbio Laboratory
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic. The text is in all caps and is relatively small compared to the central graphic.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
'JUL 1 8 2008
Stanbio Laboratory c/o Mr. Kirk Johnson QA Regulatory Affairs Manager 1261 North Main Street Boerne, Texas 78006
Re: K081719
Trade/Device Name: Stanbio Laboratory HemoPoint® H2 Hemoglobin Measurement System Regulation Number: 21 CFR 864.5620 Regulation Name: Automated hemogiobin system Regulatory Class: Class II Product Code: GKR Dated: June 16, 2008 Received: June 18, 2008
Dear Mr. Johnson:
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
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Page 2 - Stanbio Laboratory
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 cor (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anne Rouse for Maria Chen
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K081719
Device Name: Stanbio Laboratory HemoPoint® Hemoglobin Measurement System
Indications For Use:
The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.
The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and the Hemocue® measurement system. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.
Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.
For In Vitro Diagnostic Use Only
Caution: Federal law restricts this device to sale by or on the order of a physician.
Prescription Use (Part 21 GFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpert C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division/Sign-Off
of In Vitro Diagnostic Device luation and Saf
Page 1 of
510(k) K081719
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).