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 Description

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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ITC Hgb Pro Professional Hemoglobin Testing System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Summary of Performance Data, Linearity and Precision" section, where the device's performance is compared against known standards and other devices. While explicit "acceptance criteria" are not formally listed with specific thresholds as such, the reported performance demonstrates "substantial equivalence" to a standard clinical laboratory instrument (Coulter MD8) and "clinical equivalence" to the Hemocue Test System.

Table of Performance Data:

Performance Metric	Implied Acceptance Criteria / Standard	Reported Device Performance (Hgb Pro)	Notes
Linearity	Linear between 4.0 to 24.0 g/dl within 5% of the estimated linear regression line at a 95% confidence level (per NCCLS guideline EP6-P)	Linear between 4.0 to 24.0 g/dl within 5% of the estimated linear regression line at a 95% confidence level. Regression: Y=0.974x+0.264, r=0.99	Assessed with one lot of strips and 7 hemoglobin concentrations (single normal donor).
Precision (Commercial Controls)	Assessed using NCCLS EP5-T2 guidelines (no explicit threshold given, but values are reported)	Level I (Mean=6.86 g/dL): Within SD=0.17, %CV=2.41; Total SD=0.18, %CV=2.66 Level II (Mean=11.33 g/dL): Within SD=0.20, %CV=1.73; Total SD=0.25, %CV=2.17 Level III (Mean=15.63 g/dL): Within SD=0.18, %CV=1.14; Total SD=0.29, %CV=1.86	Tested repeatedly for 20 days with commercial controls (Streck, Para 4®) using 4 instruments and 2 strip lots.
Precision (Whole Blood Samples)	Assessed by comparing with Coulter MD8 Laboratory instrument (no explicit threshold given, but values are reported)	Level I (Range 6.0-6.4 g/dL, Mean=6.30): SD=0.14, %CV=2.25 Level II (Range 13.0-13.4 g/dL, Mean=13.44): SD=0.32, %CV=2.35 Level III (Range 19.4-19.9 g/dL, Mean=19.88): SD=0.39, %CV=1.97	Tested with freshly prepared whole blood samples (normal donor blood) over 3 days, using 9 instruments and 3 unique strip lots. Hemoglobin levels confirmed with Coulter MD8.
Accuracy (Hgb Pro vs. HemoCue)	Substantial equivalence (demonstrated by high correlation coefficient 'r' and regression equation close to y=x)	All ages combined: y=1.02x - 0.71, r=0.99 (venous samples) Adults only: y=1.01x - 0.62, r=0.99 (venous samples) Neonate / Pediatric: y=1.02x - 0.68, r=0.99 (venous samples) Fingerstick (Hgb Pro vs. HemoCue): y=0.78x + 3.01, r=0.78	Comparison with HemoCue, another CLIA Waived "point of care" system.
Accuracy (Hgb Pro vs. Coulter)	Substantial equivalence (demonstrated by high correlation coefficient 'r' and regression equation close to y=x)	All ages combined: y=1.01x - 0.37, r=0.99 (venous samples) Adults only: y=1.05x - 0.89, r=0.98 (venous samples) Neonate / Pediatric: y=0.99x - 0.25, r=0.99 (venous samples) Fingerstick (Hgb Pro vs. Coulter): y=0.96x + 1.18, r=0.84	Comparison with Coulter MD8 (standard clinical laboratory instrument).

Study Information:

Sample Size Used for the Test Set and Data Provenance:
- Linearity Study: 7 hemoglobin concentrations prepared from a single normal donor. Multiple Hgb Pro instruments (n=5) were tested twice at each concentration.
- Precision (Commercial Controls): n=80 for each of the three levels of commercial controls.
- Precision (Whole Blood Samples): Level I: N=87; Level II: N=90; Level III: N=90. These were freshly prepared whole blood samples from normal donors.
- Accuracy (Hgb Pro vs. HemoCue / Coulter, venous samples):
  - All ages combined: n=232 (Hgb Pro vs. HemoCue); n=226 (Hgb Pro vs. Coulter).
  - Adults only: n=162.
  - Neonate / Pediatric: n=70 (Hgb Pro vs. HemoCue); n=64 (Hgb Pro vs. Coulter).
- Accuracy (Hgb Pro vs. HemoCue / Coulter, fingerstick samples): n=87.
- Data Provenance: The document does not explicitly state the country of origin for the patient data. It mentions "Physician Office and Hospital Populations combined" and "normal donor" samples. It appears to be prospective for linearity and precision studies as samples were prepared and tested. For accuracy studies, it is implied to be clinical data from "Physician Office and Hospital Populations," which could be prospective or retrospective collections, but the wording suggests data collection for the purpose of the study.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of experts or their qualifications for establishing ground truth. The ground truth for quantitative hemoglobin measurements is typically established by reference laboratory instruments or validated methods, not by human expert opinion.
Adjudication Method for the Test Set:
- No adjudication method is mentioned as this device measures a quantitative value and does not rely on subjective interpretation by multiple readers.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. This device provides quantitative measurements, not diagnostic images or interpretations that typically involve multiple readers. The comparison is against established laboratory instruments and other point-of-care devices.
Standalone (i.e. algorithm only without human-in-the loop performance) Study:
- Yes, the performance data presented are for the standalone device (Hgb Pro system) measuring hemoglobin concentration. There is no mention of a "human-in-the-loop" component for interpretation; the device displays a numerical result. The accuracy studies compare the Hgb Pro's numerical output against other standalone devices (HemoCue and Coulter MD8).
Type of Ground Truth Used:
- Reference Instrument/Method: The primary ground truth for accuracy and precision studies was established by comparing the Hgb Pro device's readings against a standard clinical laboratory instrument (Coulter MD8) and another commercial device, the Hemocue Test System. For precision with whole blood samples, the daily-prepared control hemoglobin levels were confirmed with the Coulter MD8 Laboratory instrument. For linearity, the ground truth was derived from prepared concentrations of hemoglobin, and the expectation was linearity relative to these known concentrations.
Sample Size for the Training Set:
- The document does not specify a separate "training set" sample size. The Hgb Pro system is described as utilizing optical reflectance with a "mathematical conversion table, which is programmed into the instrument." It also states "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." This suggests that calibration and algorithm development might have used internal data, but these details are not provided as a distinct "training set." The performance data presented are primarily validation data.
How the Ground Truth for the Training Set Was Established:
- As noted above, a distinct "training set" and its ground truth establishment are not explicitly described in the provided text. The implication is that the instrument's programmed conversion table and lot-by-lot adjustments are developed and validated to align with established laboratory methods (like the Coulter MD8).

Summary

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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

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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.

Statement of Intended 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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Page 2 -

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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:

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	✓	or	Over-the- Counter Use
------------------	----------------------------------------------------------------	----	-----------------------	--

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

	Josephine Bartatik
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K023561

Regulation Number and Section

§ 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).