(103 days)
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No
The device description and performance studies focus on traditional electrophoresis and visual inspection of results, with no mention of AI or ML.
No
The device is described as an "in vitro diagnostic" test system intended for the electrophoretic separation and identification of hemoglobins. It is used to confirm the identity of clinically relevant hemoglobins, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that it is a "qualitative test system intended for the electrophoretic separation of hemoglobins to confirm the identity of clinically relevant hemoglobins". The "Device Description" also states that it is for "In-Vitro diagnostic use only".
No
The device description clearly states it is a "test kit" and involves physical components like cellulose acetate slides, staining, and destaining steps, which are hardware-based processes. While it can be automated on instruments, the core device is a physical test system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Acid Hemoglobin test kit employs cellulose acetate supported on Mylar® as the medium and is for in vitro diagnostic use."
- Device Description: The "Device Description" also explicitly states: "The InterLab Acid Hemoglobin test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only."
- Purpose: The device is intended to analyze a biological sample (whole blood) in vitro (outside the body) to provide information about a patient's health status (identifying clinically relevant hemoglobins).
- Intended User/Care Setting: The intended user is a "clinical or hospital laboratory," which is a typical setting for IVD testing.
N/A
Intended Use / Indications for Use
The Interlab Acid Hemoglobin Electrophoresis is a qualitative test system intended for the electrophoretic separation of hemoglobins to confirm the identity of clinically relevant hemoglobins such as A, F, S and C. It is to be used in conjunction with the Interlab Alkaline Hemoglobin Electrophoresis test kit. The Acid Hemoglobin test kit employs cellulose acetate supported on Mylar® as the medium and is for in vitro diagnostic use. The test can be automated on the Microtech 672 PC and Microtech 648 ISO instruments.
Product codes (comma separated list FDA assigned to the subject device)
GKA
Device Description
The InterLab Acid Hemoglobin test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Acid Hemoglobin Electrophoresis Test Devices provide qualitative identification of abnormal 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. The slides visually read to identify the bands present.
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
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Intended User / Care Setting
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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
Studies were performed using samples from both normal and suspected pathological patients submitted for routine testing to the clinical or hospital laboratory. The seventy-one (71) normal and pathological samples evaluated were tested with the InterLab Acid Hemoglobin test system run on the Microtech instrument and compared to the laboratory's routine commercially available test system following the laboratory's procedure. Comparison was accomplished exclusively by visual inspection of the electrophoretic patterns.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison Study:
Studies were performed using samples from both normal and suspected pathological patients submitted for routine testing to the clinical or hospital laboratory. The studies were run at 2 facilities and the samples were tested with the InterLab Acid Hemoglobin test system run on the Microtech instrument and compared to the laboratory's routine commercially available test system following the laboratory's procedure.
Site one: Standard procedure for Acid Hb is based on the qualitative evaluation of the electrophoretic results, when HPLC analysis of blood samples displays values of hemoglobin fractions that are outside the reference ranges (HbA2, HbF) or indicates the presence of abnormal fractions, electrophoresis is required as an additional confirmatory test. Abnormal results obtained by HPLC analysis, including either elevated concentration of normal hemoglobins (e.g. HbA2 or HbF) or appearance of variants, namely hemoglobins not normally present in red blood cells (e.g. HbS), require further investigation to assess the type of additional Hemoglobin(s) present in the sample.
Site two: Uses a commercially available Alkaline Hemoglobin Electrophoresis system to screen the patient samples. Fractions identified as potentially abnormal are run on the Acid Hemoglobin test for confirmation.
Sample Size: Seventy-one (71) normal and pathological samples.
Key Results: Complete agreement between the two systems was obtained. The InterLab Acid Hemoglobin test demonstrated equivalent band patterns to the reference tests with no false negative or false positive bands observed by visual inspection for the seventy-one (71) normal and pathological samples evaluated. This study resulted in a 100% agreement to the reference methods for the observed bands at both sites. These results demonstrate that the InterLab Acid Hemoglobin test system is substantially equivalent to the commercially available reference tests.
Analytical Sensitivity:
The InterLab Hemoglobin Test systems will detect hemoglobin bands at concentrations greater than 2.4 g/L for HbA, 1.9 g/L for Hb F, 1.6 g/L for HbS, and 1.54 g/L for HbC. 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.
Precision (Within Slide):
Study Type: Repeatability.
Sample Size: Three different serum samples were run in replicate on single slide for each instrument system (N=12 for samples B, C, A for SRE158K; N=8 for samples AA, BB, CC for SRE164K).
Key Results: The patterns were visually inspected and found to be qualitatively identical. In each lane the bands were correctly identified. No false fractions or aberrations were observed.
Precision (Slide to Slide):
Study Type: Reproducibility.
Sample Size: Three different serum samples were run in triplicate on multiple separate slides for each instrument system (N=30 for samples A, S, F for SRE158K; N=33 for samples XX, YY; N=36 for sample ZZ for SRE164K).
Key Results: The patterns were visually inspected and found to be qualitatively identical. In each lane the bands were correctly identified. No false fractions or aberrations were observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 864.7415 Abnormal hemoglobin assay.
(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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MAY - 4 2004
ATTACHMENT 8 1 8 1
SUMMARY OF SAFETY AND EFFECTIVENESS
1
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 qualitative identification of abnormal hemoglobin fractions for the electrophoretic separation of whole blood. The device trade name is the InterLab Acid Hemoglobin Electrophoresis having FDA assigned name: Electrophoretic Abnormal Hemoglobin Analysis systems, and a classification as a Class II device per 21 CFR Sec. 864.7415, with product code: GKA.
The InterLab Acid Hemoglobin test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Acid Hemoglobin Electrophoresis Test Devices provide qualitative identification of abnormal 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. The slides visually read to identify the bands present.
Studies were performed using samples from both normal and suspected pathological patients submitted for routine testing to the clinical or hospital laboratory. The studies were run at 2 facilities and the samples were tested with the InterLab Acid Hemoglobin test system run on the Microtech instrument and compared to the laboratory's routine commercially available test system following the laboratory's procedure.
Standard procedure at site one for Acid Hb is based on the qualitative evaluation of the electrophoretic results, when HPLC analysis of blood samples displays values of hemoglobin fractions that are outside the reference ranges (HbA2, HbF ) or indicates the presence of abnormal fractions, electrophoresis is required as an additional confirmatory test. Abnormal results obtained by HPLC analysis, including either elevated concentration of normal hemoglobins (e.g. HbA2 or HbF) or appearance of variants, namely hemoglobins not normally present in red blood cells (e.g. HbS), require further investigation to assess the type of additional Hemoglobin(s) present in the sample.
Site two uses a commercially available Alkaline Hemoglobin Electrophoresis system to screen the patient samples. Fractions identified as potentially abnormal are run on the Acid Hemoglobin test for confirmation. Comparison was accomplished exclusively by visual inspection of the electrophoretic patterns. Complete agreement between the two systems was obtained.
The InterLab Acid Hemoglobin test demonstrated equivalent band patterns to the reference tests with no false negative or false positive bands observed by visual inspection for the seventy-one (71) normal and pathological samples evaluated. This study resulted in a 100% agreement to the reference methods for the observed bands at both sites. These results demonstrate that the InterLab Acid Hemoglobin test system is substantially equivalent to the commercially available reference tests.
Analytical Sensitivity
The InterLab Hemoglobin Test systems will detect hemoglobin bands at concentrations greater than 2.4 g/L for HbA, 1.9 g/L for Hb F, 1.6 g/L for HbS, and 1.54 g/L for HbC. Samples were serially diluted and run on the intert ab method. The patterns were visually inspected to see
2
when the bands were no longer visible. That sample's dilution was back calculated to determine its concentration.
Precision (Within Slide)
Three different serum samples were run in replicate on single slide for each instrument system. The patterns were visually inspected and found to be qualitatively identical. In each lane the bands were correctly identified. No false fractions or aberrations were observed. The following typical results were obtained for the kits.
SRE158K
| SAMPLE | N. | Detected bands |
|---|---|---|
| B | 12 | HbF, HbA, HbC |
| C | 12 | HbA, HbC |
| A | 12 | HbF, HbA, HbS |
SRE164K
| SAMPLE | N. | Detected bands |
|---|---|---|
| AA | 8 | HbA-HbS |
| BB | 8 | HbF-HbA |
| CC | 8 | HbA-HbC |
Precision (Slide to Slide)
Three different serum samples were run in triplicate on multiple separate slides for each instrument system. The patterns were visually inspected and found to be qualitatively identical. In each lane the bands were correctly identified. No false fractions or aberrations were observed. The following typical results were obtained for the kits.
SRE158K
| SAMPLE | N. | Detected bands |
|---|---|---|
| A | 30 | HbF, HbA, HbS, HbC |
| S | 30 | HbA, HbS |
| F | 30 | HbF, HbA |
SRE164K
| SAMPLE | N. | Detected bands |
|---|---|---|
| XX | 33 | HbF, HbA1, HbS, HbC |
| YY | 33 | HbF, HbA |
| ZZ | 36 | HbA, HbS |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 4 2004
InterLab S.R.L. Mr. Gary Lehnus Trouble Shooter Consulting, Inc. 150 Cherry Lane Road East Stroudsburg, PA 18301
Re: K040146
Trade/Device Name: Interlab Acid Hemoglobin Test Systems By Eletrophoresis Regulation Number: 21 CFR 864.7415 Regulation Name: Abnormal Hemoglobin assay Regulatory Class: Class II Product Code: GKA Dated: March 30, 2004 Received: April 9, 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).
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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. Arallett
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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510(k) Number (if known): __ K040146
Interlab Acid Hemoglobin Test Systems Device Name: _________________________________________________________________________________________________________________________________________________________________
by Electrophoresis
Indications For Use:
The Interlab Acid Hemoglobin Electrophoresis is a qualitative test system intended for the electrophoretic separation of hemoglobins to confirm the identity of clinically relevant hemoglobins such as A, F, S and C. It is to be used in conjunction with the Interlab Alkaline Hemoglobin Electrophoresis test kit. The Acid Hemoglobin test kit employs cellulose acetate supported on Mylar® as the medium and is for in vitro diagnostic use. The test can be automated on the Microtech 672 PC and Microtech 648 ISO instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Division &
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040/46
x Prescription Use: (Per 21 CFR 801.109)
OR Over-The-Counter Use: (Optional Format 1-2-96)