(218 days)
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No
The description focuses on automated electrophoresis, densitometry, and software for data presentation, with no mention of AI or ML for interpretation or analysis.
No.
This device is an in vitro diagnostic (IVD) tool used for the qualitative separation and identification of immunoglobulins and their chains to aid in identifying suspected monoclonal proteins. It processes samples and provides information for diagnosis, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section states that the device is "for the qualitative in vitro diagnostic separation and identification of immunoglobulins" and "is useful as an aid in identifying suspected monoclonal proteins." This clearly indicates its role in diagnosis.
No
The device description clearly details hardware components such as the Interlab G 26 v2.0 instrument, the Easy Mask Antisera Applicator Device, gel plates, buffered sponges, stains, washing solutions, sample trays, blotters, a Peltier device, a vacuum pump, and a densitometer. While software is mentioned for instrument control and data evaluation, the device is fundamentally a system involving physical components and chemical reagents for performing electrophoresis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "for the qualitative in vitro diagnostic separation and identification of immunoglobulins... in human serum and concentrated urine". This clearly indicates the device is intended for use outside of the body (in vitro) to diagnose conditions.
- Device Description: The description details a kit containing reagents and components used to perform a test on biological samples (serum and urine). It also describes an automated analyzer designed to process these samples and reagents for diagnostic purposes.
- Summary of Performance Studies: The performance studies described (reproducibility, detection limit, interference, method comparison) are typical studies conducted to validate the performance of an in vitro diagnostic device.
- Intended User/Care Setting: The statement "For prescription use only" is also consistent with the regulatory classification of many IVD devices.
- Predicate Device(s): The mention of a predicate device with a K number (K103757) further confirms that this device is being compared to a previously cleared IVD.
All of these elements strongly indicate that this device is intended for use as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar® The test is useful as an aid in identifying suspected monoclonal proteins. The test result will be used in conjunction with clinical and other laboratory findings.
The Interlab IFE kits, (2, 4, 6 samples per gel) are intended to be used with the Automated Interlab G26 ver. 2 electrophoresis analyzer in conjunction with the Easy Mask antisera application device.
Product codes (comma separated list FDA assigned to the subject device)
CFF, DFH, DEH, CEF
Device Description
The Immunofixation Electrophoresis (IFE) Test kit is packaged as a 20 (2 samples/ gel), 40 (4 samples/ gel) or 60 (6 samples/ gel) test kits. The kit contains ready-to-use components: 10 gel plates, 2 buffered sponges, acid violet stain (500 mL), washing solution for applicators (80 mL), washing solution 1 for IFE (80 mL), washing solution 2 for IFE (80 mL), IFE diluent (6 or 12 mL), disposable sample trays 26 (10 pcs) or 39 (10 pcs), blotters A (10 pcs), blotters L (10 pcs), blotters G (10 pcs), and 1 CD Package Insert.
The following components are required for the test but are not supplied in the test kit: destain solution pack (6x100 mL), fixative solution (1.5 mL) and specific antisera Anti-Human-IgG (1 mL), Anti-Human-IgA (1 mL)), Anti-Human-IgM (1 mL), Anti-Human-Kappa (1 mL) and Anti-Human-Lambda (1 mL).
The Automated Interlab G 26 ver. 2 Electrophoresis Analyzer provides automated pipetting of samples from barcode sample tubes in a rack and dilutes the samples into a sample tray for dispensing onto an agarose gel. The protein fraction separation uses the principle of electrophoresis; separation involving electrically charged molecules that orient and migrate at different rates when subjected to an electric field. The migration is performed at a constant temperature, obtained through the use of a Peltier device, on assay specific buffered agarose gel plates. The agarose gel medium provides a support and molecular sieve allowing the different fractions to migrate to points based on individual net charges.
After electrophoresis, the gel is heated to "fix" the focalized proteins, followed by assay specific staining, destaining, washing and drying. All methods utilizing a quantitative assessment are immediately processed using the on-board densitometer. The signal obtained for each specimen result is sent to the personal computer and presented using the Elfolab interpretive software. The Interiab G26 instrument is preprogrammed with all necessary firmware to conduct and manage all phases of the analytical procedures used in Interlab manufactured assays. The instrument works in conjunction with a personal computer using Windows® based software featuring pull down menus and intuitive icons for easy instrument control, selection of analytical methods, and data evaluation.
Instrument design includes: automated application of the samples on the agarose gel; electrophoretic migration; "heat fixing" proteins to the gel; gel staining/ destaining/ drying, densitometric reading of the gel; and data transmission and processing.
The Interlab Easy Mask Antisera Applicator Device is a standalone electronic instrument identical to the peltier contained within the Interlab G26 and is designed to work in conjunction with the Interlab G26. This device allows for accurate and simplified processing of various electrophoretic agarose gel assays that require reagent or antisera overlays. This device allows for easier user processing of the manual steps necessary in antisera type assays (IFE, BJ, Penta) by allowing the user to work unencumbered from mechanical arms and instrument covers.
The Easy Mask provides functions identically to the processing steps used in other agarose gel systems that require the user to perform the manual antisera steps directly on the instrument. Through the use of a Peltier and vacuum pump, the temperature across the surface of the gel remains at a precise and controlled temperature, thus improving assay quality and decreasing time. Instrument is designed to receive the Gel Holder from the Interiab G26 Instrument. The Gel Holder is inserted into a template which places the gel in direct contact with the peliter plate assuring uniform and controlled temperature over the entire surface of the gel. Perfect adhesion of the geltier plate is accomplished using a vacuum pump. Assay specific application masks are placed in the frame, which provide precise application of the antisera or reagents during the incubation phase. After the incubation phase is complete, the frame locks over the gel providing a calibrated heated press to blot away un-bound antisera and reagents. When processing is completed on the Easy Mask, the operator places the Gel Holder back in the parking location on the Interlab G26 for the final steps of the analysis.
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
For prescription use only.
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)
Precision/Reproducibility:
-
Within-Run Reproducibility: Two series of eight samples each (one normal serum and seven sera with confirmed monoclonal bands representing all subtypes) were analyzed. For each sample, six replicates were run on agarose gel plates using the same batch of reagents. Patterns were evaluated by visual inspection.
-
Key Result: 100% agreement and reproducibility.
-
Between-Run Reproducibility: Four cycles of three agarose gel plates were used to analyze replicates of eighteen samples (three normal sera and fifteen sera with confirmed monoclonal bands representing all subtypes). Patterns were evaluated by visual inspection.
-
Key Result: 100% concordance and reproducibility.
-
Inter-Lot Reproducibility: Three different batches of antisera were used to analyze nine agarose gel plates, with nine different samples (one normal serum and eight sera with confirmed monoclonal bands, one sample for each subtype). Patterns were evaluated by visual inspection.
-
Key Result: 100% agreement and reproducibility.
Detection limit:
- Serial dilutions were prepared from three pathological serum samples containing different types of confirmed monoclonal bands (IgG k, IgA λ, and IgM K). Comparisons were made between manual dilutions run on G26v1 and dilutions made from the dilutor on G26v2. The lowest band concentration for the monoclonal component was examined by visual inspection.
- Key Results:
- IgG-Kappa: 0.05 g/L
- IgA-Lambda: 0.03 g/L
- IgM-Kappa: 0.06 g/L
Analytical specificity (Interference):
- Interference study with bilirubin, hemoglobin, and lipids in serum samples.
- Key Results: 100% agreement between spiked and un-spiked samples. No interference observed from bilirubin (up to 20 mg/dL), hemoglobin (up to 500 mg/dL), and lipemia (up to 220 mg/dL).
- Interference study with hemoglobin in urine samples.
- Key Results: 100% agreement between spiked samples. No interference observed from Hemoglobin (up to 500 mg/dL).
Method comparison with predicate device (Serum):
- Study Type: Comparison study
- Sample Size: 102 serum samples (10 normal, 92 suspected pathological)
- Comparison: Device G26 v2 (with auto-sampler) vs. FDA cleared predicate device (K103757), Interlab G26 v1 (without auto-sampler). Visual inspection of monoclonal bands.
- Key Results: 100% agreement to the reference method in identifying equivalent band patterns. No missed or additional bands observed. Neither method detected bands in normal patients. No false bands were identified.
Method comparison with predicate device (Urine):
- Study Type: Comparison study
- Sample Size: 64 urine samples (56 pathologic, 8 negative)
- Comparison: Device G26 v2 (with auto-sampler) vs. FDA cleared predicate device (K103757), Interlab G26 v1 (without auto-sampler). Visual inspection of monoclonal bands.
- Key Results: 100% agreement to the reference method in identifying equivalent band patterns. No missed or additional bands observed. Neither method detected bands in normal patients. No false bands were identified.
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.
Immunofixation Electrophoresis Test using Interlab G26 Instrument (K103757)
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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§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
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510K Summary
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMAI
A. 510(k) Number:
B. Purpose for Submission:
· New device
- C. Measurand:
Monoclonal Immunoglobulins (IgG, IgA, IgM) and light chains (kappa, lambda) in serum and urine
D. Type of Test:
Immunofixation Electrophoresis, Qualitative
E. Applicant:
Grifols Inc
F. Proprietary and Established Names:
Immunofixation Electrophoresis Test using Interlab G26 Instrument
G. Regulatory Information:
-
- Regulation section:
- 21 CFR §866.5510 Immunoglobulins (A, G, M, D, E) Immunological Test Systems 21 CFR §866.5550 Immunoglobulin (light chain specific) Immunological Test Systems
21 CFR §862.1630 Electrophoretic, Protein Fractionation
-
- Classification:
Class II
- Classification:
-
- Product code:
CFF - Immunoelectrophoretic, Immunoglobulins (G, A, M)
- Product code:
DFH - Kappa, Antigen, Antiserum, Control
DEH - Lambda, Antigen, Antiserum, Control
CEF - Electrophoretic, Protein Fractionation
-
- Panel Immunology (82) Clinical Chemistry (75)
H. Intended Use:
-
- Intended use
The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the r no intine in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar® The test is useful as an aid in identifying anne ading agarees go other . The test result will be used in conjunction with clinical and other laboratory findings.
- Intended use
The Interlab IFE kits, (2, 4, 6 samples per gel) are intended to be used with the The Interlab If E Rice (E. The Case of Conjunction with the Easy Mask antisera application device.
-
- Indication(s) for use: Same as Intended Use
- Special conditions for use statement(s):
1
For prescription use only.
4. Special instrument requirements:
Automated Interlab G26 ver. 2 electrophoresis analyzer in conjunction with the Easy Mask antisera application device and Elfolab software system version 16.1.0. (This Elfolab software system version 16.1.0 is an upgrade of version 7.3.0 previously cleared with Interlab Microgel Electrophoresis system cleared under 510(k) number K053571).
I. Device Description:
The Immunofixation Electrophoresis (IFE) Test kit is packaged as a 20 (2 samples/ gel), 40 (4 samples/ gel) or 60 (6 samples/ gel) test kits. The kit contains ready-to-use components: 10 gel plates, 2 buffered sponges, acid violet stain (500 mL), washing solution for applicators (80 mL), washing solution 1 for IFE (80 mL), washing solution 2 for IFE (80 mL), IFE diluent (6 or 12 mL), disposable sample trays 26 (10 pcs) or 39 (10 pcs), blotters A (10 pcs), blotters L (10 pcs), blotters G (10 pcs), and 1 CD Package Insert.
The following components are required for the test but are not supplied in the test kit: destain solution pack (6x100 mL), fixative solution (1.5 mL) and specific antisera Anti-Human-IgG (1 mL), Anti-Human-IgA (1 mL)), Anti-Human-IgM (1 mL), Anti-Human-Kappa (1 mL) and Anti-Human-Lambda (1 mL).
The Automated Interlab G 26 ver. 2 Electrophoresis Analyzer provides automated pipetting of samples from barcode sample tubes in a rack and dilutes the samples into a sample tray for dispensing onto an agarose gel. The protein fraction separation uses the principle of electrophoresis; separation involving electrically charged molecules that orient and migrate at different rates when subjected to an electric field. The migration is performed at a constant temperature, obtained through the use of a Peltier device, on assay specific buffered agarose gel plates. The agarose gel medium provides a support and molecular sieve allowing the different fractions to migrate to points based on individual net charges.
After electrophoresis, the gel is heated to "fix" the focalized proteins, followed by assay specific staining, destaining, washing and drying. All methods utilizing a quantitative assessment are immediately processed using the on-board densitometer. The signal obtained for each specimen result is sent to the personal computer and presented using the Elfolab interpretive software. The Interiab G26 instrument is preprogrammed with all necessary firmware to conduct and manage all phases of the analytical procedures used in Interlab manufactured assays. The instrument works in coniunction with a personal computer using Windows® based software featuring pull down menus and intuitive icons for easy instrument control, selection of analytical methods, and data evaluation.
Instrument design includes: automated application of the samples on the agarose gel; electrophoretic migration; "heat fixing" proteins to the gel; gel staining/ destaining/ drying, densitometric reading of the gel; and data transmission and processing.
The Interlab Easy Mask Antisera Applicator Device is a standalone electronic instrument identical to the peltier contained within the Interlab G26 and is designed to work in conjunction with the Interlab G26. This device allows for accurate and simplified processing of various electrophoretic agarose gel assays that require reagent or antisera overlays. This device allows for easier user processing of the
2
manual steps necessary in antisera type assays (IFE, BJ, Penta) by allowing the user to work unencumbered from mechanical arms and instrument covers.
The Easy Mask provides functions identically to the processing steps used in other agarose gel systems that require the user to perform the manual antisera steps directly on the instrument. Through the use of a Peltier and vacuum pump, the temperature across the surface of the gel remains at a precise and controlled temperature, thus improving assay quality and decreasing time. Instrument is designed to receive the Gel Holder from the Interiab G26 Instrument. The Gel Holder is inserted into a template which places the gel in direct contact with the peliter plate assuring uniform and controlled temperature over the entire surface of the gel. Perfect adhesion of the geltier plate is accomplished using a vacuum pump. Assay specific application masks are placed in the frame, which provide precise application of the antisera or reagents during the incubation phase. After the incubation phase is complete, the frame locks over the gel providing a calibrated heated press to blot away un-bound antisera and reagents. When processing is completed on the Easy Mask, the operator places the Gel Holder back in the parking location on the Interlab G26 for the final steps of the analysis.
J. Substantial Equivalence Information:
-
- Predicate device name(s) and 510(k) number(s): Immunofixation Electrophoresis Test using Interlab G26 Instrument (K103757)
| Predicate G26 ver.1 | G26 ver. 2 | |
|---|---|---|
| Instrument | Automated Interlab G26 | |
| electrophoresis | ||
| analyzer. | ||
| Instrumentation | ||
| includes the Easy Mask | ||
| antisera application | ||
| device and the Elfolab | ||
| software system. | Automated Interlab G26 | |
| electrophoresis | ||
| analyzer. | ||
| Instrumentation includes | ||
| the Easy Mask antisera | ||
| application device and | ||
| the Elfolab software | ||
| system. | ||
| Methodology | Gel Electrophoresis | Same |
| Technology | Agarose gel | |
| Electrophoretic Migration | ||
| with Immunofixation | Same | |
| Sample type | Serum and urine | Same |
| Sample size | 30 μL | Same |
| Results Interpretation | Qualitative | Same |
| Automated Application of | ||
| Samples on the Agarose Gel | Yes | Yes |
| Heat Fixing Proteins to Gel | Yes | Yes |
| Gel Staining | Yes | Yes |
| Gel Destaining | Yes | Yes |
| Gel Drying | Yes | Yes |
| Densitometric Reading of the | ||
| Gel | Yes | Yes |
-
- Comparison with predicate:
3
| Data Transmission and
| Processing | Yes | Yes |
|---|---|---|
| Positive patient ID from Tube | ||
| Barcode | No, Manual by Tech | Yes |
| Primary Tube Sampling | No, Manual by Tech | Yes |
| Sample Dilutions | No, Manual by Tech | Yes |
| Lowest Detectable Limit | Serum: | |
| IgGλ: 0.05 g/L | ||
| IgAκ: 0.03 g/L | ||
| IgMλ: 0.06 g/L | ||
| Urine: | ||
| IgGκ: 0.028 g/L | ||
| IgAλ: 0.050 g/L | ||
| IgMκ: 0.062 g/L | Serum: | |
| IgGκ: 0.05 g/L | ||
| IgAλ: 0.03 g/L | ||
| IgMκ: 0.06 g/L | ||
| Urine: | ||
| IgGκ: 0.028 g/L | ||
| IgAλ: 0.050 g/L | ||
| IgMκ: 0.062 g/L |
K. Standard/Guidance Document Referenced (if applicable):
CLSI EP-7A: Interference Testing in Clinical Chemistry
L. Test Principle:
The principle of Immunofixation electrophoresis (IFE) is based on the protein separation at alkaline pH. After protein migration, one of the gel lanes is treated with fixative to fix all proteins to provide a reference pattern and the other gel lanes are treated with specific antisera. Reaction with patient samples results in the formation of insoluble antigen-antibody complex that produces a band of precipitate when the proportion of antibodies and antigen is appropriate. The precipitation rate depends on temperature, pH, and ionic strength of the solution. The gels are washed to remove excess un-precipitated proteins, then blotters are applied to remove excess buffer twice. Gels are then stained with acid violet, de-stained and dried.
The comparison of the positions of immunofixed bands and that of the suspected monoclonal band in the reference pattern allows assessment of the biochemical identity of the protein. IFE usually displays discrete and sharply focused bands with monoclonal proteins in monoclonal gammopathies. In polyclonal gammopathies a diffuse zone is shown in the corresponding antiserum in contrast to the sharp band observed in monoclonal gammopathies.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
- a. Precision/Reproducibility:
Within-Run Reproducibility: Two series of eight samples were analyzed. For each series, one normal serum and seven sera with confirmed monoclonal bands representing all subtype were run. For series 1 were run (IgG к. IgA к, IgA λ, ίgΜ κ, igM λ, κ free), and (IgG κ. IgG λ, IgA κ, IgA λ, IgM κ, IgM λ, λ free ) for series 2. For each sample, six replicates were run on the agarose gel plates, using the same batch of reagents. Results were evaluated by visual inspection.
The Within-run precision study showed 100% agreement and reproducibility. Between-Run Reproducibility: Study was performed to evaluate the reproducibility in
4
different runs of the same batch of reagents, four cycles of three agarose gel plates were used to analyze replicates of eighteen samples (three normal sera and fifteen sera with confirmed monoclonal bands) representing all the subtype (IgG к. IgG A, IgA κ, IgA λ, IgM κ, IgM λ, λ free, κ free). Patterns obtained on the agarose gels were evaluated by visual inspection. Inter-run Precision Study showed 100% concordance and reproducibility.
The Between-run precision study showed 100% agreement and reproducibility.
Inter-Lot Reproducibility:_Study was performed to evaluate the activity of different batches of antisera. For this study, three different batches of antisera were used to analyze a series of nine agarose gel plates. Nine different samples were analyzed, one normal serum and eight sera with confirmed monoclonal bands, one sample for each subtype (IgG κ. IgG λ, IgA κ, IgA λ, IgM κ, IgM λ, λ free, κ free). Patterns were evaluated by visual inspection. Since this method is based only on a qualitative analysis, the precision was evaluated only on results accordance. The inter-lot precision study showed 100% agreement and reproducibility.
- b. Linearity/assay reportable range: Not applicable.
- c. Traceability, Stability, Expected values (controls, calibrators, or methods): No reference standards and method available.
Stability: Real time stability studies were performed on four packs of IFE Kit and four packs of antisera kit on IgG. IgAk. IgAk. IgAk. IgMk. and IgMil samples. Kits were stored at room temperature and tested every 6, 12. 18, and 24 months. The studies support the antisera stability for 24 months. Open kit and open antisera vial studies were performed on four packs of IFE Kit and four packs of antisera kit. IFE kits were stored at room temperature (15-30°C) and antisera kits were stored at 2 -- 8°C. Both open IFE kits and antisera kits were tested at 6 months. The studies support the open kit and open vial stability for 6 months.
- d. Detection limit:
Serial dilutions will be prepared from three (3) pathological serum samples containing the different types of the confirmed monoclonal bands (IgG k, IgA À, and IgM K) as shown in table A. We compared the dilution made manually and run on the G26v1 and the dilution made from the dilutor on the G26v2 (with auto sampler on board.)
For each type of the monoclonal band (IgG k, IgA λ, and IgM K), the lowest band concentration for the monoclonal component will be examined by visual inspection individually and further determined to be the detection limit.
| Monoclonal | Concentration | Detection |
|---|---|---|
| Component | Band (g/L) | Limit (g/L) |
| IgG- Kappa | 20.5 | 0.05 |
| IgA- Lambda | 22.5 | 0.03 |
| IgM- Kappa | 12.8 | 0.06 |
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e. Analytical specificity:
Interference:
An interference study was performed to evaluate if potentially interfering substances such as bilirubin, hemoglobin and lipids show interference effect with serum samples with the Interlab IFE test showed 100% agreement between spiked and un-spiked samples identifying equivalent band patterns. No missed or additional bands were observed. No bands were detected in the normal sample. No interference was observed from bilirubin (up to 20 mg/dL), hemoglobin (up to 500 mg/dL), and lipemia (up to 220 mg/dL) on the test.
Eight urine samples comprised of seven pathological bands representing a mix of all subtypes and one normal, were run on the Interlab G26 instrument. The Interlab IFE test showed 100% agreement between spiked samples identifying equivalent band patterns. No missed or additional bands were observed. No bands were observed in the normal patients. Samples show no interference effect from Hemoglobin (up to 500 mg/dL).
Applicator Carryover:
- f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
Serum
A Comparison study was performed to compare the device G26 v2 (with auto-sampler) with the FDA cleared predicate device (K103757), Interlab G26 v1 (without auto-sampler) . We performed the comparison using our FDA cleared (K103757) kits for the IFE immunofixation test; SRE627K (2 sample), SRE628K(4 sample) and SRE643K(6 sample).
The monoclonal bands from the results of the immunofixation electrophoresis kits were evaluated by visual inspection. If the monoclonal banding patterns from the new device (G26 v2) and the predicate are qualitatively identical, the result is concordant; otherwise, it is discrepant.
On both G26 v1 and v2 (with auto-sampler), a series of 102 serum samples obtained from normal (10 samples) and suspected pathological (92 samples) patients containing monoclonal and polyclonal proteins were tested using the Interlab IFE Acid Violet electrophoresis test system. The samples contained a mixture of different subtypes (IgG K. IgG λ, IgA κ, IgA λ, IgM κ, IgM λ, λ free, IgG λ & IgA λ, IgG λ & IgM λ, IgG k & IgM λ, IgG λ & λ free, IgM k & IgM λ, IgG k & IgG k).
The Interlab IFE test showed 100% agreement to the reference method in identifying equivalent band patterns. No missed or additional bands were observed in either method. Neither method detected bands in the normal patients. No false bands were identified
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| Number of samples | Concentration | Subtype | Total Serum Protein
(g/dL) |
|-------------------|---------------|-------------------------------|-------------------------------|
| 41 | 2 g/dl | IgM K/L, IgA k/ L, IgG
K/L | 11 - 13 |
| 3 | >20 mg/L | λ free | 11 |
| 10 | n.a. | Negative | 9 |
| Total 109 | | | |
Urine
A Comparison study was performed to compare the device G26 v2 (with auto-sampler) with the FDA cleared predicate device (K103757), Interlab G26 v1 ( without auto-sampler) . We performed the comparison using our FDA cleared (K103757) kits for the IFE immunofixation test, SRE627K (2 sample), SRE628K(4 sample) and SRE643K(6 sample).
The monoclonal bands from the results of the immunofixation electrophoresis kits were evaluated by visual inspection. If the monoclonal banding patterns from the new device (G26 v2) and the predicate are qualitatively identical, the result is concordant; otherwise, it is discrepant.
A mix of urine samples were run on the Interlab G26 version 1 and G26 version 2.
Samples were centrifuged at 5000 rpm for 5 min and then concentrated, if necessary, by using Millipore Minicon Concentrator in a range of 20X - 80 X. Sample were run following the manufacturer's instructions.
A total of 64 samples were run for the comparison study, the 64 samples were comprised of 56 pathologic samples and 8 Negative samples. The 64 samples were comprised of 6 samples with no detected values for total urine proteins in the 24h, 39 samples with 2000 mg/24h of total proteins in the urine.
The Interlab IFE test showed 100% agreement to the reference method in identifying equivalent band patterns. No missed or additional bands were observed in either method. Neither method detected bands in the normal patients. No false bands were identified.
| Number of
Samples | Concentration | Subtype | Total Urine Protein
(mg/24 h) |
|----------------------|---------------|-------------------|----------------------------------|
| 39 | >20 mg/L | K free and λ free | 100 mg/L | Polyclonal | >2000 |
| 6 |