(30 days)
Not Found
Not Found
No
The description details a photometric measurement system based on a chemical reaction and light transmission, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is used for quantitative determination and estimation of hematocrit, which are diagnostic purposes, not for treating any condition or disease.
Yes
The device is indicated for the quantitative determination of hemoglobin, and its intended use section states "For In Vitro Diagnostic Use Only," which identifies it as a diagnostic device.
No
The device description clearly states it is comprised of a photometer and cuvettes, which are hardware components. The photometer uses LEDs and a photodiode to measure light transmission, indicating a physical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For In Vitro Diagnostic Use Only" in the "Intended Use / Indications for Use" section.
- Intended Use: The intended use is the "quantitative determination of hemoglobin in arterial, venous, or capillary blood." This is a diagnostic measurement performed on biological samples (blood) outside of the body.
- Device Description: The description details a system that analyzes blood samples using a chemical reaction and photometric measurement to determine hemoglobin levels. This process is characteristic of in vitro diagnostics.
- Microcuvettes: The microcuvettes are designed to hold the blood sample for analysis by the system, further supporting the in vitro nature of the device.
All of these points clearly indicate that the HemoPoint® H2 Hemoglobin Measurement System is an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
GKR
Device Description
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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For In Vitro Diagnostic Use Only
Prescription Use (Part 21 GFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpert C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison To Predicate Device: Precision:
Within-run imprecision HemoPoint® H2 System and HemoPoint® H2 Cuvettes on HemoCue Device 0.995
Experimental Data:
HemoPoint® H2 System: (HemoPoint® H2 cuvettes measured in HemoPoint® H2 device):
Regression line and correlation coefficients compared to NCCLS H15-A3 reference method (g/dL), venous blood (Summary of results): Y= 0.2929 + 1.0086X; R=0.999; N=100, duplicate measurements
Regression line and correlation coefficients compared to HemoCue system (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 correlation coefficients compared to HemoCue system (g/dL), venous blood, (Summary of results): Y=-0.2181 + 1.0159X; R=0.997; N=100, duplicate measurements
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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: II | ||
| CFR: 21 CFR 864.5620 | |||
| Product Code: GKR | |||
| Manufacturer: | Stanbio Laboratory | ||
| 1261 North Main Street | |||
| Boerne, 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).
1
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 measured
in HemoPoint® H2 device | HemoPoint® H2
measured in HemoCue
device |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| 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-Day
Imprecision
Single 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
2
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 correlation
coefficients compared to NCCLS H15-A3
reference method (g/dL), venous blood
(Summary of results) | - Y= 0.2929 + 1.0086X
- R=0.999
- N=100, duplicate measurements |
|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Regression line and correlation
coefficients compared to HemoCue
system (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 correlation
coefficients compared to HemoCue
system (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 or | ||
| capillary human blood | venous, arterial or | ||
| capillary human blood | equivalent | ||
| Measuring time | Approximately | ||
| 30 - 60 sec | Approximately | ||
| 30 - 60 sec | equivalent | ||
| Measuring units | mol/L, g/dL, g/L | mol/L, g/dL, g/L | equivalent |
| Calibration | against NCCLS reference | ||
| method | against NCCLS reference | ||
| method | equivalent | ||
| Method | Azidemethemoglobin | ||
| method (Vanzetti) | Azidemethemoglobin | ||
| method (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
3
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
4
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
5
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