HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)

K991362 · Morax · JBD · Jun 21, 1999 · Hematology

Device Facts

• Record ID: K991362
• Device Name: HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
• Applicant: Morax
• Product Code: JBD · Hematology
• Decision Date: Jun 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7440
• Device Class: Class 2

Indications for Use

Sebia's HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL ACID(E) HEMOGLOBIN(E) lines of devices are intended as an aid in the detection and identification of human hemoglobin abnormalities, namely hemoglobinopathies (structural hemoglobin abnormalities) and thalassemias (regulation abnormalities). The uses are indicated as follows: The HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL MINI HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize alkaline agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams are interpreted visually for pattern abnormalities. Densitometry can serve as an aid in the interpretation by providing relative concentrations of individual fractions. The kits are intended for the normal hemoglobins (A and A2) and the major hemoglobin variants S or D and C or E. They are indicated for screening for clinically important abnormal hemoglobins. Electrophoresis on acidic gel, e.g., HYDRAGEL ACID(E) HEMOGLOBIN(E), should follow to confirm the identification of hemoglobin variants, in particular, to differentiate hemoglobins S from D and E from C. The HYDRAGEL ACID(E) HEMOGLOBIN(E) and HYDRAGEL MINI ACID(E) HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 ACID(E) HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize acid buffered agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams serve for qualitative, visual interpretation of the patterns. The kits are indicated for confirming the identity of clinically important abnormal hemoglobins that have been previously detected on alkaline buffered HYDRAGEL HEMOGLOBIN(E) gels. Primarily, they serve for differentiation of hemoglobins S from D and E from C.

Device Story

In vitro diagnostic kits for hemoglobin electrophoresis; utilizes alkaline or acid agarose gels to separate human hemoglobin fractions. Manual or semi-automated (HYDRASYS apparatus) processing; visual interpretation of electrophoregrams for pattern abnormalities; densitometry provides relative concentration data. Used in clinical laboratories by trained personnel. Alkaline gels screen for hemoglobinopathies/thalassemias; acid gels confirm variant identity (e.g., differentiating S from D, E from C). Results aid clinicians in diagnosing structural hemoglobin abnormalities and regulation disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Agarose gel electrophoresis kits; alkaline or acid buffered gels; manual or semi-automated (HYDRASYS) operation; qualitative visual interpretation; densitometry optional for quantification.

Indications for Use

Indicated for screening and confirmation of human hemoglobinopathies and thalassemias in patients. Used to identify normal hemoglobins (A, A2) and variants (S, D, C, E).

Regulatory Classification

Identification

An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

JUN 21 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Borek Janik, Ph.D. Official Correspondent Morax 13805 Waterloo Chelsea, Michigan 48118

K991362 Re:

> Trade Name: HYDRAGEL Hemoglobin (E), Mini Hemoglobin (E), 7 Hemoglobin (E), 15 Hemoglobin (E), Acid (E) Hemoglobin (E), Mini Acid (E) Hemoglobin (E), 7 Acid (E) Hemoglobin (E), and 15 Acid (E) Hemoglobin (E) Regulatory Class: II Product Code: JBD, GKA, GIQ, KQI, MLL Dated: April 9, 1999 Received: April 14, 1999

Dear Dr. Janik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

## Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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 and 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Toutman

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

Enclosure

{2}------------------------------------------------

## 510(k) Number (if known): K991362

HYDRAGEL HEMOGLOBIN(E) Device name: HYDRAGEL - MINI HEMOGLOBIN(E) HYDRAGEL 7 HEMOGLOBIN(E) HYDRAGEL 15 HEMOGLOBIN(E) HYDRAGEL ACID(E) HEMOGLOBIN(E) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------HYDRAGEL 7 ACID(E) HEMOGLOBIN(E) HYDRAGEL 15 ACID(E) HEMOGLOBIN(E)

## Indications For Use:

Sebia's HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL ACID(E) HEMOGLOBIN(E) lines of devices are intended as an aid in the detection and identification of human hemoglobin abnormalities, namely hemoglobinopathies (structural hemoglobin abnormalities) and thalassemias (regulation abnormalities). The uses are indicated as follows:

The HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL MINI HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize alkaline agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams are interpreted visually for pattern abnormalities. Densitometry can serve as an aid in the interpretation by providing relative concentrations of individual fractions. The kits are intended for the normal hemoglobins (A and A2) and the major hemoglobin variants S or D and C or E. They are indicated for screening for clinically important abnormal hemoglobins. Electrophoresis on acidic gel, e.g., HYDRAGEL ACID(E) HEMOGLOBIN(E), should follow to confirm the identification of hemoglobin variants, in particular, to differentiate hemoglobins S from D and E from C.

The HYDRAGEL ACID(E) HEMOGLOBIN(E) and HYDRAGEL MINI ACID(E) HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 ACID(E) HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize acid buffered agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams serve for qualitative, visual interpretation of the patterns. The kits are indicated for confirming the identity of clinically important abnormal hemoglobins that have been previously detected on alkaline buffered HYDRAGEL HEMOGLOBIN(E) gels. Primarily, they serve for differentiation of hemoglobins S from D and E from C.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | <div></div> |
|-----------------------------------------|-------------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K991362 |

| Prescription Use | OR | Over-The Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)O