The Randox Laboratories Limited Liquid Protein Calibrator (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assavs). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM 470. The constituent concentrations of these Calibrators are present at levels 1, 2, 3, 4 and 5. This calibrator can be used on Abbott Spectrum, Abbott aeroset, Abbott Architect ഗ്രാമം Architect i2000sr, Ace Analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra vitalab, Synchron CX4 Synchron CX5 Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira plus systems The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. For in vitro diagnostic use.
Device Story
Liquid protein calibrators derived from normal human serum; used to calibrate clinical chemistry and immunoassay systems for specific protein analytes (ASO, C3, C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, Transferrin). Supplied in 5 levels; assigned values via immunoturbidimetry against CRM 470 reference material. Used by laboratory personnel to ensure accuracy of patient sample testing on various automated analyzers. Benefits include standardized calibration across multiple instrument platforms, ensuring reliable diagnostic results for protein analytes.
Clinical Evidence
No clinical data. Bench testing only; performance established via assignment of constituent concentrations using immunoturbidimetry against International Reference Material CRM 470.
Technological Characteristics
Liquid calibrator derived from normal human serum. Multi-level (1-5) concentration format. Principle of operation: immunoturbidimetric assignment against CRM 470. Compatible with various automated clinical chemistry analyzer platforms.
Indications for Use
Indicated for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin, and Haptoglobin assays in neat human serum samples. For use by qualified laboratory personnel in clinical laboratory settings.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k061056
B. Purpose for Submission:
New Devices
C. Measurand:
Protein analytes: ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin, Haptoglobin
D. Type of Test:
Calibrators
E. Applicant:
Randox Laboratories Ltd.
F. Proprietary and Established Names:
Randox Liquid Protein Calibrators (For Neat Sample Assays)
G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150, Calibrator
2. Classification:
Class II
3. Product code:
JIX, Calibrator, Multi-Analyte Mixture
4. Panel:
Chemistry 75
H. Intended Use:
1. Intended use(s):
Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems.
2. Indication(s) for use:
The Randox Laboratories Limited Liquid Protein Calibrator (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM 470. The constituent
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concentrations of these Calibrators are present at levels 1, 2, 3, 4 and 5.
This calibrator can be used on Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000 and Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems.
The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
For in vitro diagnostic use.
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000 and Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems.
I. Device Description:
The liquid protein calibrators are supplied at 5 levels: 1, 2, 3, and 5. Target values are supplied for the following analytes in Calibrator 1, 2, 3, and 5: Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin. Target values are supplied for the following analytes in Calibrator 4: ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Bayer Specific Protein Reference Serum
Randox Liquid Protein Calibrator
2. Predicate 510(k) number:
k033791 (Haptoglobin, IgA, IgG, IgM, Transferrin, C3, C4)
k031608 (IgA, IgG, IgM, ASO, Ferritin, Prealbumin, CRP, C3, C4)
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | New Device | Predicate Device |
| Calibrator material source | Human serum | Same |
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| Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| Indication for Use | The Randox Laboratories Limited Liquid Protein Calibrators (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assays).
Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM 470. The constituent concentrations of these Calibrators are present at levels 1, 2, 3, 4 and 5.
This calibrator can be used on Abbott Spectrum, Abbott aeroset, Abbott Architect i2000, Abbott Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, | Same Indication for Use, except for the equipment listings:
(1) Bayer Predicate Device: For calibration of the ADVIA® Chemistry Systems, Technicon RA-500®, Technicon RA-1000®, Technicon® RA-XT™, Technicon RA-2000®, and opeRA® chemistry system specific protein methods.
(2) Randox Predicate Device: For Bayer ADVIA 1650 analyzer only. |
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| Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| | Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems. | |
| | The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
For in vitro diagnostic use. | |
| Calibrator level(s) | One level value for ASO and five level values for C3, C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin | The Bayer Predicate Device had one level value for C3, C4, IgA, IgG, IgM, Transferrin, Haptoglobin.
The Randox Predicate Device had one level value for ASO, CRP, Ferritin, C3, C4, Prealbumin and five level values for IgA, IgG, IgM, Transferrin |
K. Standard/Guidance Document Referenced (if applicable):
None referenced.
L. Test Principle:
Not Applicable
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable
b. Linearity/assay reportable range:
Not Applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability of the calibrators (except for ASO and Ferritin) was via the
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reference material BCR Reference Material Proteins, CRM 470; NIBSC 94-572. The reference materials for ASO and Ferritin were ‘1st IRP AST91’ and ‘NIBSC 94/572’ respectively.
## Stability
The expiration date claim was 12 months.
Open vial stability - Data included control recovery from day 0, 7, 14, 21, 30. The results ranged from - 0.8% to 4.3% which were within the acceptable criteria of ± 5% versus fresh calibrators. On day 0 of the stability study, analytes are calibrated using a freshly opened vial calibrator set. (After the required volume is removed, vials are re-capped and stored at 2-8°C). Data are recorded. The controls are then tested and controls must recover within their specified insert ranges for each analyte. On each subsequent time-points, the analytes are calibrated using previously stored open vial calibrators. Control recovery for those calibrated on open calibrator set must be within 5% to the recoveries of the control when calibrated on the freshly opened calibrator set.
Real time stability - Data included testing from day 0, 13, and 27 days at 37°C compared to material stored at recommended temperature. The results were within the acceptance criteria of ≤ 5%. On day 0 of the real time stability study, sufficient volume of the calibrator sets (enough to cover all time points) are placed at three storage temperatures (+30°, 2-8°, -80 °C). The +30 °C stability is only assessed until week 8. At 4 and 8 week time-points a set of calibrators from each of the three stored temperatures is tested. Control recoveries are run and all control material must recover within the analyte specific ranges. After week 8, only the 2-8° and -80 °C calibrator sets are tested at weeks 8, 26, 30, 52, 56, 78, 90, 104, 108.
d. Detection limit:
Not Applicable.
e. Analytical specificity:
No Applicable.
f. Assay cut-off:
Not Applicable.
2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
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.
