(73 days)
HemoCue
Not Found
No
The device description and performance studies focus on a photometric method and standard statistical analysis (precision, correlation, regression). There is no mention of AI, ML, or related concepts like training/test sets for algorithmic development.
No
This device is an in vitro diagnostic device used for measuring hemoglobin levels, not for treating a disease or condition.
Yes
The device is described as being for "In Vitro Diagnostic Use Only" and performs "quantitative determination of hemoglobin". It measures a physiological parameter which can be used to assess health status or disease, even though it explicitly states it is "not indicative of disease states such as anemia and abnormal values will not be reported" for estimated hematocrit. The primary function of determining hemoglobin levels is a diagnostic measurement.
No
The device description explicitly states it is comprised of a "HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes," which are physical hardware components. The system measures light transmitted through a cuvette using LEDs and a photodiode.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For In Vitro Diagnostic Use Only" multiple times in the Intended Use and Intended User sections.
- Intended Use: The intended use is the "quantitative determination of hemoglobin in arterial, venous, or capillary blood." This is a measurement performed on biological samples (blood) outside of the body to provide information about a person's health status.
- Device Description: The description details a system that analyzes a blood sample placed in a microcuvette using photometric measurement. This is a typical method for in vitro diagnostic testing.
- Regulatory Language: The caution "Federal law restricts this device to sale by or on the order of a physician" is common language for medical devices, including IVDs.
Therefore, based on the provided information, the HemoPoint® H2 Hemoglobin Measurement System is clearly 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/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
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 cvanmethemoglobin method. which is also known as the cvanhemoglobin 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 desoxyhemodlobin are oxidised by the reagent potassium hexacvanoferrate (II) 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 mm. This absorption is proportional to the tHb concentration.
In 1966. Vanzetti suggested to replace KCN by NaN, and thus was able to reduce the toxicity of the reagent mixture considerably.
Vanzetti's method is also known as the azide methemoqlobin method. A modified azide methemoqlobin 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.
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
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: Precision:
Within-run imprecision HemoPoint® H2 System and HemoPoint® H2 Cuvettes on HemoCue Device ≤ 2%
Hemoglobin/high (17.3 g/dL): Within-Run Precision (NCCLS EP5-A): Swr 0.111 g/dL, CV 0.6 % (HemoPoint® H2 device); Swr 0.103 g/dL, CV 0.6 % (HemoCue device)
Total Precision (NCCLS EP5-A): ST 0.207 g/dL, CV 1.2 % (HemoPoint® H2 device); ST 0.162 g/dL, CV 0.9 % (HemoCue device)
Hemoglobin/low (10.7 g/dL) Within-Run Precision (NCCLS EP5-A): Swr 0.095 g/dL, CV 0,9% (HemoPoint® H2 device); Swr 0.068 g/dL, CV 0,6% (HemoCue device)
Total Precision (NCCLS EP5-A): ST 0.114 g/dL, CV 1.1% (HemoPoint® H2 device); ST 0.086 g/dL, CV 0.8% (HemoCue device)
Hemoglobin/normal (12.9 g/dL) Within-Run Precision (NCCLS EP5-A): Swr 0.084 g/dL, CV 0.7% (HemoPoint® H2 device); Swr 0.102 g/dL, CV 0.8% (HemoCue device)
Total Precision (NCCLS EP5-A): ST 0.148 g/dL, CV 1.1% (HemoPoint® H2 device); ST 0.134 g/dL, CV 1.0% (HemoCue device)
Between-Day Imprecision Single observation, 20 days:
HemoPoint® H2 cuvette measured in HemoPoint® H2 device: 10.7 g/dL: SD 0.102 g/dL, CV 1.0 %; 12.9 g/dL: SD 0.141 g/dL, CV 1.1 %; 17.3 g/dL: SD 0.169 g/dL, CV 1.0 %
HemoPoint® H2 measured in HemoCue device: 10.9 g/dL: SD 0.094 g/dL, CV 0.9 %; 13.0 g/dL: SD 0.126 g/dL, CV 1.0 %; 17.2 g/dL: SD 0.148 g/dL, CV 0.9 %
Correlation Study:
Correlation coefficient HemoPoint® H2 System compared to NCCLS H15-A3 reference method, venous blood: > 0.98
Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: ≥ 0.97
Experimental Data:
HemoPoint® H2 System: (HemoPoint® H2 cuvettes measured in HemoPoint® H2 device):
Regression line correlation and coefficients compared to NCCLS H15-A3 reference method (g/dL), venous blood (Summary from 4 Clinical Study Sites): Y= 0.023 + 1.006X, R=0.999, N=174, duplicate measurements, Range 3.31 g/dL to 24.4 g/dL
Regression line correlation and coefficients compared to HemoCue system (g/dL), venous blood, (Summary from 4 Clinical Study Sites): Y= - 0.233 +1.001X, R=0.998, N=286, duplicate measurements, Range 3.25 g/dL to 23.85 g/dL
HemoPoint® H2 cuvettes measured in HemoCue device:
Regression line and correlation coefficients compared to HemoCue system (g/dL), venous blood, (Summary from 4 Clinical Study Sites): Y= 0.139 +986X R=0.999 N=286, duplicate measurements Range 3.25 g/dL to 23.85 g/dL
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.
HemoCue
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
OCT 2 4 2003
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K032482'. The characters are written in a clear, handwritten style, with each digit and letter easily distinguishable. The sequence appears to be a code or identifier, possibly a serial number or a reference code.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
(As required bv 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 cvanmethemoglobin method. which is also known as the cvanhemoglobin 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 desoxyhemodlobin are oxidised by the reagent potassium hexacvanoferrate (II) 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 mm. This absorption is proportional to the tHb concentration.
In 1966. Vanzetti suggested to replace KCN by NaN, 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 methemoqlobin 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 source on the left side, an absorbing solution in the middle, and a detector on the right side. The light source emits light with intensity P0, which passes through the absorbing solution with thickness b, and the detector measures the intensity of the light after it has passed through the solution, which is P.
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 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/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
(17.3 g/dL):
Within-Run Precision
(NCCLS EP5-A): | Swr 0.111 g/dL, CV 0.6 % | Swr 0.103 g/dL, CV 0.6 % |
| Total Precision
(NCCLS EP5-A): | ST 0.207 g/dL, , CV 1.2 % | ST 0.162 g/dL, CV 0.9 % |
| Hemoglobin/low
(10.7 g/dL)
Within-Run Precision
(NCCLS EP5-A): | Swr 0.095 g/dL, CV 0,9% | Swr 0.068 g/dL, CV 0,6% |
| Total Precision
(NCCLS EP5-A): | ST 0.114 g/dL, CV 1.1% | ST 0.086 g/dL, CV 0.8% |
| Hemoglobin/normal
(12.9 g/dL)
Within-Run Precision
(NCCLS EP5-A): | Swr 0.084 g/dL, CV 0.7% | Swr 0.102 g/dL, CV 0.8% |
| Total Precision
(NCCLS EP5-A): | ST 0.148 g/dL, CV 1.1% | ST 0.134 g/dL, CV 1.0% |
| Between-Day
Imprecision
Single observation,
20 days | 10.7 g/dL: SD 0.102 g/dL, CV 1.0 %
12.9 g/dL: SD 0.141 g/dL, CV 1.1 %
17.3 g/dL: SD 0.169 g/dL, CV 1.0 % | 10.9 g/dL: SD 0.094 g/dL,
CV 0.9 %
13.0 g/dL: SD 0.126 g/dL,
CV 1.0 %
17.2 g/dL: SD 0.148 g/dL,
CV 0.9 % |
Correlation Study:
Correlation coefficient HemoPoint® H2 System compared to NCCLS H15-A3 reference method, venous blood: > 0.98
Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: ≥ 0.97
$$\mathbf{2} - \mathbf{3}$$
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
correlation
| and | Y= 0.023 + 1.006X | ||
|---|---|---|---|
| coefficients compared to NCCLS H15-A3 | R=0.999 | ||
| reference method (g/dL), venous blood | N=174, duplicate measurements | ||
| (Summary from 4 Clinical Study Sites) | Range 3.31 g/dL to 24.4 q/dL | ||
| Regression | |||
| line | |||
| correlation | |||
| and | Y= - 0.233 +1.001X | ||
| coefficients | |||
| compared to HemoCue | R=0.998 | ||
| system (g/dL), venous blood, | N=286, duplicate measurements | ||
| (Summary from 4 Clinical Study Sites) | Range 3.25 g/dL to 23.85 g/dL |
HemoPoint® H2 cuvettes measured in HemoCue device':
| Regression line and correlation coefficients compared to HemoCue system (g/dL), venous blood, (Summary from 4 Clinical Study Sites) | Y= 0.139 +986X R=0.999 N=286, duplicate measurements Range 3.25 g/dL to 23.85 g/dL |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
Comparison to Predicate Device:
| Specification | HemoPoint® H2 | HemoCue | 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 - 23.5 g/dL | equivalent |
| Specified accuracy | $\pm$ 0.3 g/dL at ≈14 g/dL | $\pm$ 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 | measuring time depends on the concentration |
| Measuring units | mol/L, g/dL, g/L | mol/L, g/dL, g/L | equivalent |
| Calibration | against NCCLS reference method | against ICSH reference method | NCCLS is current version of the method |
| Method | Azidemethemoglobin method (Vanzetti) | Azidemethemoglobin method (Vanzetti) | equivalent |
Conclusion / Substantial Equivalence:
The HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes and the predicate devices, HemoCue B-Hemoglobin System with microcuvette are substantially equivalent based on design and function.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
OCT 2 4 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Kirk Johnson QA/Regulatory Affairs Manager Stanbio Laboratory 1261 North Main Street Boerne, Texas 78006
Re: K032482
Trade/Device Name: Stanbio Laboratory HemoPoint® Hemoglobin Measurement System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: II Product Code: GKR Dated: August 5, 2003 Received: August 12, 2003
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 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.
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Page 2 -
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 yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Ko32482
510(k) Number (if known):
Stanbio Laboratory HemoPoint® Hemoglobin Measurement System Device Name:
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.
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032482
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR801.109)
OR
Over the Counter Use
(Optional Format 1-2-96)