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

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 Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a device called HYDRAGEL Hemoglobin (E). It does not contain the detailed information necessary to answer all aspects of your request. The document describes the device's intended use and FDA's determination of substantial equivalence to predicate devices, but it does not detail a study conducted to establish acceptance criteria or demonstrate performance in the way a clinical trial report would.

However, I can extract some information based on the typical regulatory context of such devices.

Here's what can be inferred or directly stated from the provided text, along with what cannot be answered:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. A 510(k) often focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data from a new, standalone study for the device itself. The document mentions "electrophoregrams are interpreted visually for pattern abnormalities" and "Densitometry can serve as an aid in the interpretation by providing relative concentrations of individual fractions," which are methods of interpretation, but not performance metrics or acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not present in the provided 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present in the provided 510(k) summary. The document states that "electrophoregrams are interpreted visually for pattern abnormalities," implying human interpretation, but does not specify the number or qualifications of interpreters.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not present in the provided 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not present in the provided 510(k) summary. The device described (HYDRAGEL Hemoglobin (E)) is an in vitro diagnostic electrophoresis kit, and as such, it predates widespread AI assistance in this specific application. The document describes visual interpretation and densitometry, which are human-centric methods.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not present in the provided 510(k) summary. Given the nature of the device as an electrophoresis kit with visual interpretation, it's highly unlikely that a standalone algorithm-only performance study was conducted or would even be relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated in the provided 510(k) summary. However, for a device intended to aid in the detection and identification of hemoglobin abnormalities, the ground truth would typically be established by:

Reference methods: Other established, highly accurate laboratory tests for hemoglobin variants.
Clinical diagnosis: Confirmation through patient clinical presentation and other diagnostic findings.
Expert interpretation: Consensual agreement among experienced laboratory professionals specializing in hemoglobinopathies.
The document states the device is intended for "screening for clinically important abnormal hemoglobins" and "confirming the identity of clinically important abnormal hemoglobins," implying that the outcome of these tests would need to align with established clinical knowledge.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. This type of device (electrophoresis kit) is not "trained" in the machine learning sense. Its performance relies on the biochemical principles of electrophoresis and the reagents provided.

9. How the ground truth for the training set was established

This question is not applicable as there is no "training set" in the context of this device. The device itself (the kit and electrophoretic method) is the "system," and its performance is evaluated against established diagnostic accuracy, not by training an algorithm.

Summary

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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.

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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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

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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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
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

Regulation Number and Section

§ 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).