(147 days)
No
The description details a photometric method based on Lambert-Beers Law and standard data management features, with no mention of AI or ML.
No.
The device is used for the quantitative determination of hemoglobin, which is a diagnostic measurement, not a therapeutic intervention.
Yes.
Explanation: The device is described as "For In Vitro Diagnostic Use Only" and is used for the "quantitative determination of hemoglobin in arterial, venous, or capillary blood," which are diagnostic measurements.
No
The device description clearly states the system is comprised of a photometer (hardware) and cuvettes (hardware/consumable), in addition to the data management software. The core function of measuring hemoglobin relies on the photometer's hardware components (LEDs, photodiode) and the chemical reaction in the cuvettes.
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 device is intended for the "quantitative determination of hemoglobin in arterial, venous, or capillary blood." This is a measurement performed on biological samples taken from the body, which is a core characteristic of IVDs.
- Device Description: The description details a chemical reaction (modified azide methemoglobin method) and measurement of light transmission through a blood sample in a microcuvette. This process is performed in vitro (outside the body) on a biological specimen.
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 HemoPoint H2 Microcuvettes are indicated for use in the HemoPoint® H2 DM Hemoglobin 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.
The DM (Data Management) system allows enhanced data management features.
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 cyanmethemoglobin 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 NaN3 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/Figure/10 description: The image shows a diagram of an absorbing solution with concentration c. The diagram shows a light source on the left side, with a light beam of intensity Pg passing through an absorbing solution of thickness b. The light beam exits the solution on the right side with a reduced intensity P. The diagram illustrates the principle 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).
The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information.
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
Not Found
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: (Data presented with K081719 submission) Precision:
Within-run imprecision HemoPoint® H2 System and HemoPoint® H2 Cuvettes on HemoCue Device 0.998
Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: > 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 |
Comparison to Predicate Device:
| Specification | HemoPoint® H2 (Predicate device) | HemoPoint® H2 (New submission) | Comments |
|---|---|---|---|
| Instrument | No. 1 | No. 2 | No.1 No. 2 |
| 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 | +/- 0.3 g/dL at ~ 14 g/dL | +/- 0.3 g/dL at ~ 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 |
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.
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
(As required by 21 CFR 807.92)
Trade Name: HemoPoint® H2 DM Hemoglobin Measurement System Common/Classification Name: Automated Hemoglobin System Device Classification: Class: Il CFR: 21 CFR 864.5620 Product Code: GKR JUN 1 0 2009 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 cyanmethemoglobin 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 NaN3 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/Figure/10 description: The image shows a diagram of an absorbing solution with concentration c. The diagram shows a light source on the left side, with a light beam of intensity Pg passing through an absorbing solution of thickness b. The light beam exits the solution on the right side with a reduced intensity P. The diagram illustrates the principle 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).
2 - 2
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
The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information.
Comparison To Predicate Device: (Data presented with K081719 submission) 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):
Within-Run Precision
(NCCLS EP5-A): | Swr 0.087 g/dL, CV 0.5% | Swr 0.102 g/dL, CV 0.7% |
| 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)
Within-Run Precision
(NCCLS EP5-A): | Swr 0.070 g/dL, CV 0.6% | Swr 0.105 g/dL, CV 0.9% |
| 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)
Within-Run Precision
(NCCLS EP5-A): | Swr 0.058 g/dL, CV 0.7% | Swr 0.068 g/dL, CV 0.8% |
| 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% |
2-3
2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CONT'D
Correlation Study:
Correlation coefficient HemoPoint® H2 System compared to NCCLS H15-A3 reference method, venous blood: > 0.998
Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: > 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) | $Y= -0.2181 + 1.0159X$
$R=0.997$
$N=100, duplicate measurements$ |
| ----------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------ |
|---|
Comparison to Predicate Device:
| Specification | HemoPoint® H2
(Predicate device) | HemoPoint® H2 (New
submission) | Comments |
|--------------------|----------------------------------------------|----------------------------------------------|------------------------------|
| Instrument | No. 1 | No. 2 | No.1 $\leftrightarrow$ No. 2 |
| 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 |
3
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CONT'D
Conclusion / Substantial Equivalence:
The modified software 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
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Stanbio Laboratory c/o Mr. Kirk Johnson OA/Regulatory Affairs Manager 1261 North Main Street Boerne, TX 78006
JUN 1 0 2009
Re: K090093
Trade/Device Name: HemoPoint® H2 DM Hemoglobin Measurement System Regulation Number: 21 CFR §864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: Class II Product Code: GKR Dated: May 27, 2009 Received: May 28, 2009
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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing vour device as described in your Section 5:10(k) premarket notification. The FDA finding of
5
Page 2 - Mr. Kirk Johnson
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 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" (21 CFR 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. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ia m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K090093
Device Name: Stanbio Laboratory HemoPoint® H2 DM 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 HemoPoint H2 Microcuvettes are indicated for use in the HemoPoint® H2 DM Hemoglobin 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.
The DM (Data Management) system allows enhanced data management features.
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 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Nemul Jr.
Division Sign-Off
Division Sign-Off
510kl
| Office of In Vitro Diagnostic | |
|---|---|
| Device Evaluation and Safety | |
| 1/1 - - - - - - - - - - - - - - - - - - - - - - |
Kog nog a
Page 1 of __