← Product Code [GKA](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA) · K040146

# INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K040146)

_Interlab S.R.L. · GKA · May 4, 2004 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K040146

## Device Facts

- **Applicant:** Interlab S.R.L.
- **Product Code:** [GKA](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA.md)
- **Decision Date:** May 4, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7415
- **Device Class:** Class 2
- **Review Panel:** Hematology

## 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.

## Device Story

System performs qualitative hemoglobin electrophoresis to identify Hb A, F, S, and C fractions. Input: hemolyzed red blood cell samples. Process: samples applied to cellulose acetate strips on Mylar support; electrophoresis separates hemoglobin based on migration rates influenced by temperature, pH, and ionic force; post-separation, strips undergo washing, staining (Ponceau red), destaining, and clearing. Output: visually identifiable stained hemoglobin bands on strips; optionally quantitated via densitometry. Used in clinical laboratory settings; operated by trained laboratory personnel. Results assist clinicians in hemoglobinopathy identification. Benefits: provides standardized, automated identification of clinically relevant hemoglobin variants.

## Clinical Evidence

Bench testing only. Study evaluated 71 normal and pathological samples across two clinical sites. Comparison against routine laboratory methods (HPLC or Alkaline Hemoglobin Electrophoresis) showed 100% agreement in band identification. Analytical sensitivity reported as 2.4 g/L (HbA), 1.9 g/L (HbF), 1.6 g/L (HbS), and 1.54 g/L (HbC). Precision studies (within-slide and slide-to-slide) confirmed qualitative identity of bands across replicates.

## Technological Characteristics

Medium: Cellulose acetate on Mylar. Energy: Electrophoresis (electrical current). Reagents: Running buffer, Ponceau red stain, destaining/clearing solutions. Automation: Compatible with Microtech 672 PC and 648 ISO instruments (robotic arm sample handling). Connectivity: Open system. Sterilization: Not applicable (reagents).

## Regulatory 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.

## Special Controls

*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.

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K040146

B. Purpose for Submission:
To show substantial equivalence to the predicate device for separation of abnormal hemoglobin fractions by electrophoresis with the use of cellulose acetate supported on Mylar®.

C. Analyte:
Hemoglobin Fractions

D. Type of Test:
Qualitative, Hemoglobin Electrophoresis

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

F. Proprietary and Established Names:
InterLab Acid Hemoglobin Electrophoresis Test System

G. Regulatory Information:
1. Regulation section:
21 CFR 864.7415
2. Classification:
Class II
3. Product Code:
GKA
4. Panel:
Hematology (81)

H. Intended Use:
1. Intended use(s):
The InterLab Acid Hemoglobin Electrophoresis Test System 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 the Microtech 648 ISO instruments

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2. **Indication(s) for use:**
The InterLab Acid Hemoglobin Electrophoresis Test System 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 the Microtech 648 ISO instruments.

3. **Special condition for use statement(s):**
Not applicable

4. **Special instrument Requirements:**
The Cellulose Acetate supported on Mylar® strips are for use on the Microtech 672 PC and the Microtech 648 ISO instruments. These instruments employ the use of a robotic arm that moves the strip to the different stations. The instruments are offered as "open systems" and are considered Class I Exempt based on 21 CFR 862.2485, product code JJN.

I. **Device Description:**
The InterLab Acid Hemoglobin Electrophoresis Test System provides identification of clinically relevant hemoglobins such as A, F, S and C visually by staining of the separate fractions. The kit contains materials for 24 runs. There are two kits available (SRE164K and SRE158K) providing the ability to run 192 or 288 tests. Each kit contains the following: testing strips, running and soaking buffer, staining solution, destaining solution, and clearing solution. All reagents are ready to use.

J. **Substantial Equivalence Information:**
1. **Predicate device name(s):**
Paragon, Beckman Coulter
2. **Predicate K number(s):**
K834595
3. **Comparison with predicate:**

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | InterLab Acid Electrophoresis Test System | Paragon Acid Hemoglobin  |
|  Intended Use | Separation of hemoglobins to confirm the identity of clinical relevant hemoglobins such as A,F,S and C. | Same  |
|  Method | Electrophoresis | Same  |
|  Sample | Hemolyzed separated red blood cells using distilled | Hemolyzed separated red blood cells using  |

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|   | water | hemolyzing solution  |
| --- | --- | --- |
|  Sample application | Pipetting Station | Same  |
|  Results | Visual or quantitated by densitometry | Visual or quantitated by densitometry  |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  Support Medium | Cellulose Acetate on Mylar | Agarose Gel  |
|  Reagents | Running Buffer
Staining Solution (Ponceau red)
Destaining Solution
Clearing Solution | Maleic Acid Buffer
Violet Stain Solution
Hemolyzing Reagent
Destaining Solution
Required but Not Supplied:
Glacial Acidic Acid
Methanol
Deionized Water  |
|  Equipment | Microtech 684 ISO System
Microtech 672 PC System | Paragon Electrophoresis
System  |

K. Standard/Guidance Document Referenced (if applicable):
Not provided

L. Test Principle:
The principle of acid hemoglobin electrophoresis is based upon the visualization of specific hemoglobin bands following separation by electrophoresis. Hemolysates made from whole blood patient specimens are placed in separate lanes of a cellulose acetate slide. The major hemoglobin groups (Hb A, C, F and S) 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 are visually read to identify the bands present.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Intra-assay
The intra-assay precision was measured using an acid hemoglobin control (AFSA2) and two different patient samples run in replicates (8 and 12). The patterns were visually inspected and found to be qualitatively identical.
Inter-assay
Inter-assay precision was measured using one abnormal control (AFSC) and two different patients run in replicates (3 each) for 10-11 cellulose acetate strips over three-four days. The patterns were visually inspected and found qualitatively identical.

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b. Linearity/assay reportable range:
Not applicable

c. Traceability (controls, calibrators, or method):
Not applicable

d. Detection limit:
An abnormal control with known concentration values was serially diluted and run using the InterLab Acid Hemoglobin Electrophoresis Test System. The degree of band visibility showed detection of 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.

e. Analytical specificity:
Ineffective centrifugation and/or RBC washing with saline solution will not yield a clear hemolysate. This may result in the presence of a red line at the application point, which is indicative of a poor quality electrophoretic pattern. The Acid Hemoglobin test is not recommended for quantitation of increased levels of HbF. The point of sample application should not be visible in the pattern. If the application point is present as a line strongly stained, expect a smeared pattern, with poor resolution and substandard focusing of the bands. Deviation from the recommended test procedure may affect the results.

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Comparison studies were performed by visual inspection of the electrophoretic patterns on 71 normal and suspected pathological patients. The InterLab Acid Hemoglobin Electrophoresis Test System demonstrated equivalent band patterns to the predicate with no false negative or false positive bands observed. The study resulted in a 100% agreement.

b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical sensitivity:
Not applicable
b. Clinical specificity:
Not applicable

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c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K040146](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K040146)

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