The IT/IF Control is designed for the qualitative quality control of the detection and characterization of human monoclonal immunoglobulins (IgG, IgA, IgM, Kappa and Lambda) with the electrophoresis methods: - Immunotyping performed using capillary electrophoresis on SEBIA MINICAP instrument, - Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber. The IT/IF Control is designed for laboratory use. It should be used (with its barcode label for MINICAP procedure) like a human serum sample. The electrophoretic pattern obtained is specific for each batch of IT/IF control. For in vitro diagnostic use.
Device Story
IT/IF Control is a stabilized, lyophilized human serum pool containing monoclonal immunoglobulins (IgG, IgA, IgM, Kappa, Lambda). Used as a quality control material in clinical laboratories to verify performance of Sebia electrophoresis systems (MINICAP, HYDRASYS, K20 chamber). Laboratory personnel process the control like a patient serum sample. The device produces a specific electrophoretic pattern used to confirm the qualitative detection and characterization of monoclonal proteins by the instrument. Concordance of these patterns across different instrument configurations ensures system accuracy and reliability for clinical decision-making regarding monoclonal gammopathy identification.
Clinical Evidence
No clinical data. Bench testing only. Performance was validated through analytical studies comparing the IT/IF Control against the predicate device across multiple Sebia instrument configurations (MINICAP, HYDRASYS 1/2, K20 chamber). Studies confirmed concordant and reproducible identification of IgG Lambda, IgA Lambda, and IgM Kappa monoclonal proteins across within-run and between-run testing using different antisera lots.
Technological Characteristics
Lyophilized human serum pool containing monoclonal immunoglobulins (IgG, IgA, IgM, Kappa, Lambda). Designed for use with capillary electrophoresis (MINICAP) and immunofixation electrophoresis (HYDRASYS/K20). Stability: 3 years at 2-8°C (unopened); 1 week at 2-8°C or 2 months at -18 to -22°C (reconstituted).
Indications for Use
Indicated for qualitative quality control of human monoclonal immunoglobulin (IgG, IgA, IgM, Kappa, Lambda) detection and characterization via electrophoresis. Intended for laboratory use as a human serum sample surrogate.
Regulatory Classification
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k101863
B. Purpose for Submission:
New device
C. Measurand:
Quality Control for Monoclonal Immunoglobulins (IgG, IgA, IgM, Kappa, Lambda)
D. Type of Test:
Assayed quality control material
E. Applicant:
SEBIA INC, USA
F. Proprietary and Established Names:
IT/IF Control
G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660 – Quality Control Material (Assayed and Unassayed)
21 CFR §866.5510 – Immunoglobulins A, G, M, D, and E Immunological Test System
21 CFR §866.5550 – Immunoglobulin (Light Chain Specific) Immunological Test System
2. Classification:
Class I Reserve (control); Class II (test system);
3. Product code:
JJY – Multi-Analyte Controls, All Kinds (Assayed)
CFF – Immunoelectrophoretic, Immunoglobulins (G, A, M)
DFH – Kappa, Antigen, Antiserum, Control
DEH – Lambda, Antigen, Antiserum, Control
4. Panel:
Immunology (82); Chemistry (75)
H. Intended Use:
1. Intended use:
The IT/IF Control is designed for the qualitative quality control of the detection and characterization of human monoclonal immunoglobulins (IgG, IgA, IgM, Kappa and Lambda) with the electrophoresis methods:
- Immunotyping performed using capillary electrophoresis on SEBIA MINICAP instrument,
- Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT/IF Control is designed for laboratory use. It should be used (with its barcode label for MINICAP procedure) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT/IF control.
For in vitro diagnostic use.
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2. Indication(s) for use:
Same as Intended use.
3. Special conditions for use statement(s):
For prescription only.
4. Special instrument requirements:
This device has been validated for use with the following SEBIA instruments:
- MINICAP System (capillary electrophoresis) cleared in k073002
- HYDRASYS 1 and HYDRASYS 2 (IF) cleared in k960029
- HYDRASYS 1 Focusing and HYDRASYS 2 Focusing (IF) cleared in k033277
- HYDRASYS 2 Scan cleared in k960029
- HYDRASYS 2 Scan Focusing cleared in k033277
- HYDRASYS 2 Isofocusing cleared in k063498
- SEBIA K20 electrophoresis chamber (IF) cleared in k951536
I. Device Description:
The IT/IF Control is obtained from a pool of human sera complemented with monoclonal immunoglobulins displaying the 5 specificities G, A, M, Kappa and Lambda.
The IT/IF Control is supplied in a stabilized lyophilized form.
J. Substantial Equivalence Information:
1. Predicate device name(s) and Predicate k number(s):
Beckman Paragon CZE® IFE/s Control 2000, k002799
2. Comparison with predicates:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For the detection and characterization of monoclonal immunoglobulins. | Same |
| Results | Qualitative Monoclonal Protein Interpretation | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Indication for Use/Intended Use | The IT/IF Control is designed for the qualitative quality control for the detection and characterization of human monoclonal immunoglobulins (IgG, IgA, IgM, Kappa and Lambda) with the electrophoresis methods:
- immunotyping performed using capillary electrophoresis on | Paragon CZE® 2000 IFE/s (Immunofixation Electrophoresis by subtraction) Control is for use with the Paragon CZE® 2000 system and related IFE/s reagents to assure correct immunosubtraction by the system. The Control provides a qualitative test to identify human IgG kappa, IgA lambda, IgM kappa proteins by |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | SEBIA Minicap instrument.
- immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber. | immunosubtraction. |
| Instrument(s) | Minicap Immunotyping (MiniCapillarys) instrument; Hydrasys and Hydrasys 2 electrophoresis instruments and the K20 electrophoresis chamber. | Paragon CZE® 2000 IFE/s |
| Matrix | Human serum | Human plasma |
| Form | Lyophilized | Liquid |
| Packaging and Volume | 1 Bottle Reconstituted to 1 mL | 3 Bottles x 3 mL each |
| Storage Stability | Lyophilized at 2-8°C for 3 years.
Reconstituted aliquots at 2-8°C for 1 week;
Reconstituted aliquots at -18 to -22°C for 2 months
Frreze/ thaw cycle: 20 cycles | Unopened bottles at 2-8°C for 18 months.
Opened bottles at 2-8°C for 45 days. |
| Preparation for Use | Use upon reconstitution | Use upon 1:2 dilution |
K. Standard/Guidance Document Referenced (if applicable):
Not applicable.
L. Test Principle:
Not applicable.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
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a. Comparison with Predicate and Precision/Reproducibility studies:
Two sets of aliquots of one lot of IT/IF control device were tested on IT capillaries and IFE gels (different IFE gel configurations in different SEBIA IFE instruments were used) as follows:
Minicap Immunotyping Instrument: IT/IF control was run 3 times on 2 capillaries within a run and the run was repeated with 3 different lots of antisera for 3 days. The new device displayed IgG Lambda, IgA Lambda, and IgM Kappa monoclonal proteins in the Minicap capillary electrophoretograms. The identified monoclonal proteins were concordant and reproducible for the within-run and between-run IT Capillarys qualitative results.
HYDRASYS Systems (Hydrasys 1 & 2; Hydrasys Focusing 1 & 2; Hydrasys Scan Isofocusing 1 & 2): The SEBIA IT/IF control was run 3 times on 3 each of the 6 different gel configurations within a run and the run was repeated with 3 different lots of antisera for 3 days. The 6 different gel configurations were as follows: 4IF Acid Violet, 4IF Amido Black, 9IF Gel, 4 Bence Jones (BJ) Gel, 9 BJ Gel and 12 IF Penta Gel. The IT/IF control displayed IgG Lambda, IgA Lambda, and IgM Kappa monoclonal proteins in their respective gel configurations. The identified monoclonal proteins were concordant and reproducible for the within-run and between run IF agarose gel qualitative results.
K20 electrophoresis chamber: The SEBIA IT/IF control was run 3 times on 3 sets of gels each of the 3 different gel configurations within a run and the run was repeated with 3 different lots of antisera for 3 days. The 2 different gel configurations were: IF Penta Gel; Single IF; Double IF. The IT/IF controls displayed IgG Lambda, IgA Lambda, and IgM Kappa monoclonal proteins in their respective gel configurations. The identified monoclonal proteins were concordant and reproducible for the within-run and between run IF gel qualitative results.
b. Linearity/assay reportable range:
Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Unopened bottle accelerated stability study: Two lyophilized lots of SEBIA IT/IF control were tested upon storage at room temperature weekly at week 1, 2, 3, 4, 5, 6, 7, 8 and 3 months. All IT/IF results met the qualitative acceptance criteria. Real time studies are ongoing to support the 3 year expiry dating indicated on the lyophilized bottles when stored at 2-8°C.
Open reconstituted bottle stability study: Two lots of SEBIA IT/IF control were reconstituted and then stored at different temperatures (2-8°C, -18 to -22°C) for different periods of time before the testing. For 2-8°C stability study, scheduled target testing dates were week 1, 2, 3, 4, 5 and 6. For -18 to -22°C stability study, scheduled target testing dates were week 1; week 4; week 8 or 2 months, and 3 months. In addition, freeze/thaw studies were performed by storing frozen control aliquots at -18 to -22°C then thawed and refrozen weekly for a total of 30 cycles at the following cycle intervals: 1, 5,
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8, 11, 13, 15, 16, 20, and 30. All IT and IF results met the qualitative acceptance criteria. Open reconstituted control bottle stability claims are: 1 week at 2-8°C; 2 months at -18 to -22°C; and freeze/thaw for no more than 20 cycles within 2 months of reconstitution when stored at -18 to -22°C.
d. Detection limit:
Not applicable.
e. Analytical specificity:
Not applicable.
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
Two aliquots of one lot of IT/IF control device and two aliquots of one lot of Beckman IFE control were tested on both IT capillaries and IFE gels (different IFE gel configurations in different SEBIA IFE instruments were used) as follows:
Minicap Immunotyping Instrument: Control aliquots were run 3 times on 2 capillaries within a run and the run was repeated with 3 different lots of antisera for 3 days. Both the new and predicate controls identified the IgG Lambda, IgA Lambda, and IgM Kappa monoclonal proteins and were concordant in the Minicap IT capillary electrophoretograms.
HYDRASYS Systems (Hydrasys 1 & 2; Hydrasys Focusing 1 & 2; Hydrasys Scan Isofocusing 1 & 2): Control aliquots were run 3 times on 3 each of the 6 different gel configurations within a run and the run was repeated with 3 different lots of antisera for 3 days. The 6 different gel configurations were as follows: 4IF Acid Violet, 4IF Amido Black, 9IF Gel, 4 Bence Jones (BJ) Gel, 9 BJ Gel and 12 IF Penta Gel. Both new and predicate controls identified the IgG Lambda, IgA Lambda, and IgM Kappa monoclonal proteins and were concordant in all the different gel configurations.
K20 electrophoresis chamber: Control aliquots were run 3 times on 3 sets of gels each of the 3 different gel configurations within a run and the run was repeated with 3 different lots of antisera for 3 days. The 2 different gel configurations were: IF Penta Gel; Single IF; Double IF. One Beckman control was tested with the SEBIA control runs. The new and predicate controls identified the IgG Lambda, IgA Lambda, and IgM Kappa monoclonal proteins and were concordant in all the different gel configurations.
b. Matrix comparison:
Not applicable.
3. Clinical studies:
a. Clinical Sensitivity and specificity:
Not applicable.
b. Other clinical supportive data (when a. is not applicable):
Not applicable.
4. Clinical cut-off:
Not applicable.
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5. Expected values/Reference range:
Not applicable.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
