ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM

K023561 · International Technidyne Corp. · GKR · Jan 31, 2003 · Hematology

Device Facts

• Record ID: K023561
• Device Name: ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
• Applicant: International Technidyne Corp.
• Product Code: GKR · Hematology
• Decision Date: Jan 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5620
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Hgb Pro Professional Hemoglobin Testing System™ consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use. For In Vitro Diagnostic Use Only

Device Story

Portable, battery-operated meter for near-patient hemoglobin testing. Input: capillary or venous (EDTA) whole blood applied to single-use test strip containing membrane with dried lysing reagent. Operation: blood lyses on membrane; meter uses optical reflectance to measure hemoglobin concentration. Output: total hemoglobin concentration (g/dL or mmol/L) displayed in <30 seconds. Used by healthcare professionals in clinical facilities. Meter uses programmed mathematical conversion table to calculate results; allows lot-specific adjustments to ensure accuracy against laboratory standards. Benefits: rapid, point-of-care hemoglobin quantification for clinical decision-making.

Clinical Evidence

Clinical validation included linearity testing (4.0–24.0 g/dL, r=0.99) and precision studies (20-day protocol using commercial controls and 3-day protocol using whole blood). Accuracy compared against Coulter MD8 and HemoCue across adult and pediatric/neonate populations (n=232 for HemoCue, n=226 for Coulter). Results showed high correlation (r=0.98–0.99) for venous samples. Fingerstick sample correlation was lower (r=0.78–0.84).

Technological Characteristics

Portable, battery-operated meter. Sensing principle: optical reflectance. Test strips: single-use, membrane-based with dried red cell lysing reagent. Measurement range: 4.0–24.0 g/dL. Connectivity: standalone. Software: embedded, rule-based calculation using mathematical conversion tables with lot-specific adjustments.

Indications for Use

Indicated for quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood in professional clinical settings. Not for home use.

Regulatory Classification

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.

Predicate Devices

• Coulter MD8 (Beckman Coulter, Inc.)
• Hemocue Test System

Submission Summary (Full Text)

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ITC

JAN 3 1 2003

### 510 (k) Summary

ITC Hgb Pro Professional Hemoglobin Testing System™

This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: KO3350

October 21, 2002 Prepared:

Submitted by: John Clay

> International Technidyne Corp. 6 Olsen Ave. Edison, NJ 08820 (732-548-5700) Ext. 265 (732-548-2325) Fax

#### Device Name

| Common / Usual Name: | Whole Blood Hemoglobin Test System |
|----------------------|-----------------------------------------------------|
| Product Name: | ITC Hgb Pro Professional Hemoglobin Testing System™ |

## Predicate Device

The Hgb Pro Professional Hemoglobin Testing System™ is substantially equivalent to the a standard clinical laboratory instrument (Coulter MD8) (Beckman Coulter, Inc. Fullerton, CA). The Hgb Pro was also compared to the Hemocue Test System to demonstrate clinical equivalence to another CLIA Waived "point of care" Hemoglobin Test System.

## Device Description and Technological Characteristics

The Hgb Pro Professional Hemoglobin Testing System™ consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use.

The Hgb Pro meter utilizes optical reflectance for determination of total hemoglobin. The test strip, containing a membrane preloaded with a dried reagent containing a red cell lysing agent, is inserted into the meter. A drop of whole blood is applied to the test location on the strip after a

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baseline reading is taken. Blood immediately disperses within the membrane, resulting in lysis of red blood cells and release of hemoglobin. The meter's optical detectors automatically measure the change in membrane reflectance.

The meter calculates and displays the total hemoglobin concentration in grams/deciliter (s/dL, equivalent to percent) or millimole/L) based on a mathematical conversion table, which is programmed into the instrument. Minor adjustments may be made to the conversion on a lot-by-lot basis based on variation of the raw materials and process to ensure accuracy with the laboratory system. The test result will be displayed in 30 seconds or less.

# Statement of Intended Use

The Hgb Pro Professional Hemoglobin Testing System™ consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use.

For In Vitro Diagnostic Use Only

# Summary of Performance Data, Linearity and Precision

# Linearitv

The linearity of the Hgb Pro system was tested using one lot of Hgb Pro strips and seven (7) hemoglobin concentrations prepared from a single normal donor. Multiple Hgb Pro instruments (n=5) were tested twice at each concentration. The data were analyzed using the NCCLS guideline EP6-P "Evaluation of the linearity of Ouantitative Analytical Methods". The Hgb Pro Hemoglobin Testing System is linear between 4.0 to 24.0 g/dl within 5% of the estimated linear regression line at a 95% confidence level. The linearity regression curve is: Y=0.974x+0.264, r=0.99

# Precision studies

The total precision of the Hgb Pro Professional Hemoglobin Testing System was calculated from the testing of commercial controls on multiple days. The Hgb Pro system was tested repeatedly for 20 days with commercially available controls as per NCCLS EP5-T2. The testing for the protocol evaluated three levels of commercial controls (Streck, Para 4®) in four (4) instruments with two lots of Hgb strips. The data in Table 1 was obtained for within run and total precision of the Hgb Pro System.

| Table 1 | Level I (n=80) | | Level II (n=80) | | Level III (n=80) | |
|-----------|----------------|-------|-----------------|-------|------------------|-------|
| Precision | Within | Total | Within | Total | Within | Total |
| Mean | 6.86 | 6.86 | 11.33 | 11.33 | 15.63 | 15.63 |
| SD | 0.17 | 0.18 | 0.20 | 0.25 | 0.18 | 0.29 |
| %CV | 2.41 | 2.66 | 1.73 | 2.17 | 1.14 | 1.86 |

Additionally, precision of the Hgb Pro system was calculated from testing of freshly prepared whole blood samples created to specified hemoglobin concentrations. Samples were prepared from normal donor blood hemo-diluted or hemo-concentrated to manipulate hgb concentration.

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Multiple Hgb Pro instruments were tested repeatedly for 3 days. The hemoglobin levels of the daily-prepared controls were confirmed with the Coulter MD8 Laboratory instrument (Beckman Coulter Inc., Fullerton, CA) and are shown in Table 2 as "Range". Three levels of venous whole blood samples were tested with 5 instruments each day. Over the 3 days, a total of 9 instruments and 3 unique lots of strips were evaluated. Precision across strip lots, instruments and days is shown in Table 2.

| Table 2 | Level I | Level II | Level III |
|---------|-----------|-------------|-------------|
| Range | 6.0 - 6.4 | 13.0 - 13.4 | 19.4 - 19.9 |
| Mean | 6.30 | 13.44 | 19.88 |
| SD | 0.14 | 0.32 | 0.39 |
| %CV | 2.25 | 2.35 | 1.97 |
| N | 87 | 90 | 90 |

#### Accuracy

Physician Office and Hospital Populations combined, Regression Analysis Summary Hgb Pro and HemoCue Testing Performed in HOSPITAL LAB with VENOUS SAMPLES

| Data | Equation | r | n |
|----------------------------------------|----------------|------|-----|
| Hgb Pro vs. HemoCue, all ages combined | y=1.02x - 0.71 | 0.99 | 232 |
| Adults only | y=1.01x - 0.62 | 0.99 | 162 |
| Neonate / Pediatric | y=1.02x - 0.68 | 0.99 | 70 |
| Hgb Pro vs. Coulter, all ages combined | y=1.01x - 0.37 | 0.99 | 226 |
| Adults only | y=1.05x - 0.89 | 0.98 | 162 |
| Neonate / Pediatric | y=0.99x - 0.25 | 0.99 | 64 |

Hgb Pro and HemoCue tested using FINGERSTICK samples, Coulter tested with venous samples

| Data | Equation | r | n |
|---------------------|------------------|------|----|
| Hgb Pro vs. HemoCue | $y=0.78x + 3.01$ | 0.78 | 87 |
| Hgb Pro vs. Coulter | $y=0.96x + 1.18$ | 0.84 | 87 |

#### Conclusion

Clinical validation results demonstrate the Hgb Pro system is substantially equivalent to a standard laboratory instrument Coulter MD-8 and meets the ITC performance requirements specified within the new diagnostic product specifications for the system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The eagle is facing right, and the profiles are arranged in a cascading manner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

JAN 3 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John Clay Director, Regulatory Affairs International Technidyne Corporation 8 Olsen Avenue Edison, NJ 08820

Re: k023561

Trade/Device Name: Hgb Pro Professional Hemoglobin Testing System™ Regulation Number: 21 CFR 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Code: GKR Dated: October 21, 2002 Received: October 23, 2002

Dear Mr. Clay:

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).

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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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Steven Sutman

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

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# 510(k) Number (If Known): K Og 35 6 (

Device Name: Hgb Pro Professional Hemoglobin Testing System™

Indications for Use:

The Hgb Pro Professional Hemoglobin Testing System™ consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use.

For In Vitro Diagnostic Use Only

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> | or | Over-the- Counter Use | |
|------------------|----------------------------------------------------------------|----|-----------------------|--|
|------------------|----------------------------------------------------------------|----|-----------------------|--|

Per 21 CFR 801.109 (Optional Format 1-2-96)

| | <div> Josephine Bartatik </div> |
|-----------------------------------------|----------------------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023561 |