K Number
K053571
Device Name
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
Manufacturer
Date Cleared
2006-06-30

(190 days)

Product Code
Regulation Number
864.7440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semiquantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglish hemoglobin electrophoresis is necessary. The electrophoretic test is performed at allialine pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemogram patism belief allows the pattern allows the relative automated Microod instrument automated Microgel instrument. The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnomal or variant hemoglobins, and to confirm the identify of clinication of hemoglobins such as A. E. Gand O. Th hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnes and of The Rold Hemoglouin test Kit Employs agarose gel at acidid Microgel instrument Microgel instrument.
Device Description
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More Information

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No
The summary describes a traditional electrophoresis test kit and densitometry for quantification, with no mention of AI or ML technologies.

No
The device is described as a test kit for identifying hemoglobins using electrophoresis, and an "in vitro diagnostic" device, which indicates it is for diagnosis and not treatment.

Yes
The "Intended Use / Indications for Use" section states that the test kit is for "qualitative and semiquantitative determination of normal hemoglobins... as well as certain abnormal or variant hemoglobins" and provides a "valuable screening method for hemoglobin patterns." These are typical functions of a diagnostic device, aiming to identify a condition or abnormality. Furthermore, it explicitly mentions "in vitro diagnosis" in the second paragraph.

No

The device description is not found, but the intended use and mentions of densitometry and an "automated Microgel instrument" strongly suggest this is a hardware-based electrophoresis system with associated reagents, not a software-only device.

Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The text for the Microgel Acid Hemoglobin Electrophoresis kit explicitly states it is "for in vitro diagnes and of". While there's a typo, the clear intent is "in vitro diagnostics".
  • Intended Use: Both test kits are described as being used for the "qualitative and semiquantitative determination" or "identification" of hemoglobins. This involves testing biological samples (blood, presumably) outside of the body to diagnose or screen for conditions related to hemoglobin. This is a core function of IVDs.
  • Test Kit: The description refers to the products as "test kits," which are commonly used in IVD applications.

Therefore, the intended use and the explicit statement in the description strongly indicate that these devices are IVDs.

N/A

Intended Use / Indications for Use

The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semiquantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglish hemoglobin electrophoresis is necessary. The electrophoretic test is performed at allialine pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemogram patism belief allows the pattern allows the relative automated Microod instrument automated Microgel instrument.

The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnomal or variant hemoglobins, and to confirm the identify of clinication of hemoglobins such as A. E. Gand O. Th hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnes and of The Rold Hemoglouin test Kit Employs agarose gel at acidid Microgel instrument Microgel instrument.

Product codes

JBD

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 864.7440 Electrophoretic hemoglobin analysis system.

(a)
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.(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/1 description: The image shows a circular logo. The logo features a stylized eagle with outstretched wings, rendered in black. The eagle is positioned in the center of the circle. Encircling the eagle is text, which appears to be the name of an organization or agency. The text is also in black and follows the curve of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Interlab, S.R.L. c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301

JUN 3 0 2006

Re: K053571

Trade/Device Name: Microgel Hemoglobin Test Systems by Electrophoresis Regulation Number: 21 CFR § 864.7440 Regulation Name: Electrophoretic Hemoglobin Analysis System Regulatory Class: II Product Code: JBD Dated: June 2, 2006 Received: June 5, 2006

Dear Mr. Lehnus:

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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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 (240) 276-0484. 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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, Par Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ___K053571

Device Name: Microgel Hemoglobin Test Systems by Electrophoresis

Indications For Use:

The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semiquantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglish hemoglobin electrophoresis is necessary. The electrophoretic test is performed at allialine pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemogram patism belief allows the pattern allows the relative
automated Microod instrument automated Microgel instrument.

The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnomal or variant hemoglobins, and to confirm the identify of clinication of
hemoglobins such as A. E. Gand O. Th hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnes and of The Rold Hemoglouin test Kit Employs agarose gel at acidid
Microgel instrument Microgel instrument.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Josephine Buutudi
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053571

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