STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090

K020138 · Gds Technology · KHG · Feb 11, 2002 · Hematology

Device Facts

• Record ID: K020138
• Device Name: STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
• Applicant: Gds Technology
• Product Code: KHG · Hematology
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7500
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Stat-Site® M Hgb System is for in-vitro diagnostic use only. The Stat-Site® M Hgb Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® M Hgb meter.

Device Story

Stat-Site® M Hgb System is an in-vitro diagnostic device for quantitative hemoglobin measurement in whole blood. System comprises a meter and test cards. Used in physician offices and professional point-of-care settings by healthcare professionals. Provides rapid hemoglobin results to assist clinicians in assessing patient anemia status or blood health. Operates via test card analysis; specific measurement principle not detailed in provided text. Output allows immediate clinical decision-making regarding patient care.

Clinical Evidence

No clinical data provided in the document; 510(k) clearance based on substantial equivalence determination.

Technological Characteristics

System consists of a meter and test cards for quantitative hemoglobin determination in whole blood. Class II device, product code KHG. In-vitro diagnostic use.

Indications for Use

Indicated for quantitative determination of hemoglobin in whole blood for adults, children, and infants in physician offices or professional point-of-care settings.

Regulatory Classification

Identification

A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

Special Controls

*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of what appears to be three abstract human figures or forms, stacked vertically.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 1 1 2002

Richard Tyhach, Ph.D. Vice President, R & D GDS Technology 25235 Leer Drive Elkhart, IN 46514

k020138 Re:

K020130
Trade/Device Name: Stat-Site® M*** System Whole Blood Hemoglobin Assay Regulation Number: 21 CFR 864.7500 Regulation Name: Whole blood hemoglobin assays Regulatory Class: Class II Product Code: KHG Dated: January 15, 2002 Received: January 16, 2001

## Dear Dr. Tyhach:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreases 976, the enactment date of the Medical Device Amendments, or to commerco pror to ride 2017 3) in accordance with the provisions of the Federal Food, Drug, devices that hat voon require approval of a premarket approval application (PMA). and Cosmetic (1 tor) the the device, subject to the general controls provisions of the Act. The I ou may, dicrorolo, mainer 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 If your device is elassinod (overal controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 r toase of action and i termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I outhall the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A rate 0773 regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

D

Enclosure

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## Indications for Use Statement

| 501(k)<br>Number : | K020138 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name : | Stat-Site® M ^Hgb System Whole Blood Hemoglobin Assay |
| Indications for<br>Use: | The Stat-Site® M ^Hgb System is for <i>in-vitro</i> diagnostic<br>use only. The Stat-Site® M ^Hgb Test Card is intended for the<br>quantitative determination of hemoglobin in whole blood. It<br>is intended for use with the Stat-Site® M ^Hgb meter. |
| | Target Population:<br>Stat-Site® M ^Hgb is for use with adults, children, and infants. |
| | Environment of Use:<br>Physician's office or other Professional Point of Care<br>setting. |

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jaychian Bautista.

(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K220138

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use _

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