The Interlab Alkaline Hemoglobin Electrophoresis test system is intended for the separation of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using cellulose acetate supported on Mylar®. The test is a screening method for in vitro diagnostic use on the Microtech 672 PC and the Microtech 648 ISO fully automated analyzers. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary.

Device Description

The InterLab Hemoglobin devices test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Alkaline Hemoglobin Electrophoresis Test Devices provide semi-quantitative identification of hemoglobin bands visualized by staining of the fractions. The principle of hemoglobin electrophoresis is based upon the visualization of specific hemoglobin bands following separation by electrophoresis. Dilutions of a patient's specimen are placed on separate tracks (fingers) on a cellulose acetate slide six fingers shaped, and the major hemoglobin groups are separated by electrophoresis. The migration rate depends on the temperature, pH, ionic force of the solution and proportions of the reactants. After electrophoresis, the slide is processed to remove excess soluble materials through a washing step. Fractionated hemoglobins are stained. The excess of stain is removed by a destaining step.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study that demonstrates the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to a commercially available reference method and the statistical results (correlation coefficients, precision metrics) achieved.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (SRE157K)	Reported Device Performance (SRE205K)
Method Comparison	Equivalent band patterns to reference method; No false negatives/positives; Correlation coefficients ≥ 0.99; 100% agreement to reference for observed bands.	Equivalent patterns; No false negatives/positives; All correlation coefficients ≥ 0.99 (A1, F, S: 1.00; A2: 0.99); 100% agreement.	Equivalent patterns; No false negatives/positives; All correlation coefficients ≥ 0.99 (A1, S: 1.00; F, A2: 0.99); 100% agreement.
Analytical Sensitivity	Detect hemoglobin bands at concentrations ≥ 0.40 mg/mL.	Detected bands at concentrations ≥ 0.40 mg/mL.	Detected bands at concentrations ≥ 0.40 mg/mL.
Precision (Within Slide) - Qualitative	Qualitatively identical band patterns; Correctly identified bands; No false negatives/positives.	Qualitatively identical patterns; Correctly identified bands; No false negatives/positives.	Qualitatively identical patterns; Correctly identified bands; No false negatives/positives.
Precision (Slide to Slide) - Qualitative	Qualitatively identical band patterns; Correctly identified bands; No false negatives/positives.	Qualitatively identical patterns; Correctly identified bands; No false negatives/positives.	Qualitatively identical patterns; Correctly identified bands; No false negatives/positives.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 93 samples (from both normal and suspected pathological patients).
Data Provenance: Retrospective, as samples were "submitted for routine testing to the hospital laboratory." The country of origin is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts or their qualifications. It mentions that comparative studies were done against "the laboratory's routine commercially available agarose gel test system following the manufacturers' procedure." This implies that the results from the reference method, presumably interpreted by qualified laboratory personnel, served as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to be established by the results of the reference agarose gel test, which implies a single reference result per sample rather than a consensus among multiple readers for the test set itself.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not indicated. This device is an in-vitro diagnostic test system for semi-quantitative identification of hemoglobin bands, not an AI-assisted diagnostic tool that aids human readers. The comparison is between two laboratory testing methods.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is described as an "electrophoretic hemoglobin analysis system" that performs semi-quantitative identification of bands after processing. While it runs on "fully automated analyzers" (Microtech 672 PC and Microtech 648 ISO), the identification of bands and their comparison to a reference method (agarose gel test) implies that the system outputs results, and these results (band patterns) are then visually inspected and compared. The study data focuses on the performance of the test system itself, suggesting standalone performance in generating the patterns. However, the qualitative assessment ("visually inspected") suggests human interpretation is still involved in confirming results against the reference.

7. The Type of Ground Truth Used

The ground truth for the method comparison and agreement studies was established by a reference method, specifically "the laboratory's routine commercially available agarose gel test system."

8. The Sample Size for the Training Set

The document does not mention the use of a separate training set. The study described uses 93 samples for performance evaluation, compared against a reference method. This appears to be a validation/verification study, not a development study involving a distinct training phase for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for an algorithm, this question is not applicable to the provided information.

Summary

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510 (k) PREMARKET NOTIFICATION

INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST

The device name, including the trade name or proprietary name and the (a) common name of the device.

Interlab Alkaline Hemoglobin Electrophoresis test system TRADE NAME:

COMMON NAME: . Electrophoretic hemoglobin analysis system

The establishment registration number, if applicable, of the owner or (b) operator submitting the Premarket notification submission.

InterLab Scientific Instruments srl Via Rina Monti NN 26 C.A.P. 00155 Rome, ITALY

Establishment Registration Number: 3003961883

Exclusive U.S. Distributor: ADALTIS 754 Roble Road, Suite 70 Allentown, PA 18109

Establishment Registration Number: 9011134

(c) The class in which the device has been put under section 513 of the Act and, if known. its appropriate panel: or. if the owner or operator determines that the device has not been classified under this section, a statement of that determination and the basis for the person's determination that the device is not so classified.
Based upon a review of the Classification of Devices section of 21 CFR, Part 864, Electrophoretic hemoglobin analysis system of the type manufactured by InterLab have been categorized as Class II medical devices by the Hematology and Pathology Devices Panel as defined in, 21 CFR 864.7440. Product Code JBD

Action taken by the person required registering to comply with the (d) requirements of the Act under section 514 for performance standards.

This device will comply with all performance standards developed for this type of product.

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K0328462

STATEMENT OF STAFETY AND EFFECTIVENESS

The sponsor. InterLab srl. has developed, manufactured, and tested under Good Laboratory Practices guidelines, in vitro diagnostic (IVD) devices for semi-quantitative testing of whole blood for the electrophoretic separation of hemoglobin in a screening format. The device trade name is the InterLab Alkaline Hemoglobin Electrophoresis having FDA assigned name: Electrophoretic Hemoglobin Analysis systems, and a classification as a Class II device per 21 CFR Sec. 864.7440, with product code: JBD.

Studies were performed using 93 samples from both normal and suspected pathological patients submitted for routine testing to the hospital laboratory. The samples were evaluated with the InterLab Hemoglobin test systems (SRE157K and SRE205K) run on the respective Microtech instruments and compared to the laboratory's routine commercially available agarose gel test system following the manufacturers' procedure.

The InterLab Hemoglobin test kits demonstrated equivalent band patterns to the aqarose qel test with no false negative or false positive bands observed by visual inspection. This study resulted in a correlation coefficients greater than 0.99 and yielded a 100% agreement to the reference method for the observed bands. These results demonstrate that the InterLab Alkaline Hemoglobin test systems are substantially equivalent to the commercially available reference test. The results of the testing are shown in the tables below.

SRE157K

HemoglobinFraction	Slope	y-Intercept	CorrelationCoefficient
A1	0.98	1.84	1.00
F	0.97	0.15	1.00
S	0.98	0.34	1.00
A2	1.00	0.08	0.99

SRE205K

HemoglobinFraction	Slope	y-Intercept	CorrelationCoefficient
A1	1.00	0.19	1.00
F	0.86	1.23	0.99
S	0.92	2.54	1.00
A2	0.99	-0.01	0.99

Analytical Sensitivity

The InterLab Hemoglobin Test systems will detect hemoglobin bands at concentrations greater than 0.40 mg/mL. HbF and HbS samples were serially diluted and run on the InterLab method. The patterns were visually inspected to see when the bands were no longer visible. That sample's dilution was back calculated to determine its concentration.

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Precision (Within Slide)

An abnormal control and serum sample were run in replicate on single gel. The patterns were visually inspected and found to be qualitatively identical. In each lane the bands were correctly identified. No false negatives or positives were observed. The following typical results were obtained for the kits.

SRE157K

HemoglobinFraction	Mean	SD	CV (%)
A1	35.38	0.32	0.91
F	23.38	0.56	2.38
S	21.91	0.66	3.01
A2	1.99	0.08	4.02
C	19.29	0.56	2.89

SRE205K

HemoglobinFraction	Mean	SD	CV (%)
A1	32.81	0.77	2.35
F	25.66	0.62	2.43
S	21.88	0.66	3.04
A2	1.92	0.05	2.60
C	19.65	0.41	2.09

Precision (Slide to Slide)

An abnormal control and a patient sample were run in replicate on multiple separate gels. The patterns were visually inspected and found to be qualitatively identical. In each lane the bands were correctly identified. No false negatives or positives were observed. The following typical results were obtained for the kits.

SRE157K

HemoglobinFraction	Mean	SD	CV (%)
A1	36.01	0.57	1.56
F	23.43	0.64	2.74
S	21.54	0.71	3.30
A2	2.00	0.11	5.50
C	19.02	0.48	2.55

SRE205K

HemoglobinFraction	Mean	SD	CV
A1	34.22	1.24	3.63
F	23.97	0.64	2.67
S	22.45	0.63	2.82
A2	1.56	0.07	4.48
C	19.35	0.53	2.76

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized wing or feather shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Interlab Scientific Instruments SRL c/o Mr. Gary Lehnus Trouble Shooter Consulting, Inc. 150 Cherry Lane Road East Stroudsburg, PA 18301-8804

Re: K032862

Trade/Device Name: Interlab Alkaline Hemoglobin Test Systems by Electrophoresis Regulation Number: 21 CFR § 864.7440 Regulation Name: Electrophoretic Hemoglobin Analysis System Regulatory Class: II Product Code: JBD Dated: January 14, 2004 Received: January 23, 2004

FEB - 3 2004

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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Page 2

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). 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/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Arlertt

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page _1_of 1

510(k) Number (if known):

Device Name: Interlab Alkaline Hemogiobin Test Systems

by Electrophoresis

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

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K032862

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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).