CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (10^9/L), RBC (10^12/L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10^9/L), MPV (fL), NEU (%), NEU (10^9/L), LYM (%), LYM (10^9/L), MON (10^9/L), EOS (%), EOS (10^9/L), BAS (%), BAS (10^9/L)
Device Story
CELL-DYN 22 Plus Control is an in-vitro diagnostic product used for quality control of the CELL-DYN Emerald 22 hematology system. The control consists of stabilized human red blood cells, human/mammalian/simulated white blood cells, and a platelet component in a preservative medium. It is provided in three levels (low, normal, high) in polypropylene vials. Laboratory personnel use the control to verify system performance by comparing measured values against the provided assay sheet. Consistent performance of the control ensures the accuracy and precision of patient sample analysis on the hematology analyzer. The product requires refrigerated storage (2-10°C).
Clinical Evidence
No clinical data. Bench testing only. Precision/reproducibility evaluated using three lots of control material across seven CELL-DYN Emerald 22 instruments at three sites. Repeatability assessed via 10 consecutive runs per vial. All %CV values for measured parameters were within acceptable thresholds. Stability testing (open-vial 8-day and closed-vial 75-day) confirmed performance consistency over the claimed shelf life.
Technological Characteristics
Stabilized human/mammalian red blood cells, white blood cells, and platelet component in preservative medium. Polypropylene vials with polyethylene-lined caps. 2.5 mL volume. Storage 2-10°C. Designed for use with Abbott CELL-DYN Emerald 22 hematology analyzer. Complies with CLSI EP5-A2 (precision) and CLSI H26-A2 (validation/verification) guidelines.
Indications for Use
Indicated for use as an assayed hematology control to evaluate the accuracy and precision of the CELL-DYN Emerald 22 system in clinical laboratory settings.
Regulatory Classification
Identification
A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
Special Controls
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Predicate Devices
Para 12 Plus (k901875)
Submission Summary (Full Text)
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1
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k111211
B. Purpose for Submission:
Clearance of a new device
C. Measurand:
Assayed parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEU%, LYM%, MON%, EOS%, BAS%, NEU#, LYM#, MON#, EOS#, and BAS#.
D. Type of Test:
Quantitative
E. Applicant:
Streck Inc.
F. Proprietary and Established Names:
CELL-DYN 22 Plus Control
G. Regulatory Information:
1. Regulation section:
21 CFR § 864.8625, Hematology quality control mixture
2. Classification:
Class II
3. Product code:
GLQ - Mixture, control, white cell and red cell indices
4. Panel:
Hematology (81)
H. Intended Use:
1. Intended use(s):
CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN 22 system.
Assayed parameters include: WBC (10⁹/L), RBC (10¹²/L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10⁹/L), MPV (fL), NEU(%), NEU (10⁹/L), LYM (%), LYM (10⁹/L), MON (%), MON (10⁹/L), EOS (%), EOS (10⁹/L), BAS (%), BAS (10⁹/L).
2. Indication(s) for use:
Same as intended use
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
CELL-DYN Emerald 22
I. Device Description:
CELL-DYN 22 Plus Control is an in-vitro diagnostic product that contains stabilized human red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The control vials are made of polypropylene plastic with polyethylene-lined screw caps, containing 2.5 mL of control material. Three different levels (low, normal, and high) of each
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vial will be packaged in a six or twelve vacuum formed clamshell container with the product information sheet/assay sheet. The product must be stored at 2-10°C.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Para 12 Plus
2. Predicate K number(s):
k901875
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device: CELL-DYN 22 Plus | Predicate: Para 12 Plus |
| Intended Use | CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN 22 system.
Assayed parameters include: WBC (10^{9}/L), RBC (10^{12}/L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10^{9}/L), MPV (fL), NEU (%), NEU (10^{9}/L), LYM (%), LYM (10^{9}/L), MON (%), MON (10^{9}/L), EOS (%), EOS (10^{9}/L), BAS (%), BAS (10^{9}/L). | Para 12 Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide a white blood cell differential.
Same assayed parameters |
| Closed Vial Stability | 75 days | Same |
| Reagents | The product may contain any or all of the following: stabilized human or mammalian red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. | Same |
| Storage Conditions | 2-10°C | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device CELL-DYN 22 Plus | Predicate Para 12 Plus |
| Open Vial Stability | 8 days | 7 days |
K. Standard/Guidance Document Referenced (if applicable):
CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
CLSI H26-A2, Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard-Second Edition
L. Test Principle:
The tri-level CELL-DYN 22 Plus Control is designed to evaluate the accuracy and precision of the Abbott CELL-DYN Emerald 22 instrument for CBC and 5-part differential.
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M. Performance Characteristics:
1. Analytical performance:
a. Precision/Reproducibility:
Run-to-run repeatability was performed using three lots of the CELL-DYN 22 Plus Control. Repeatability was tested using 10 consecutive runs per vial of each level of control using the CELL-DYN Emerald 22 instrument. All associated data recovered within the parameter specific assay range assignments with %CV values within acceptable limits.
Run-to-run repeatability was also evaluated by direct comparison with fresh whole blood: Repeatability was assessed in 10 runs using a fresh K₂EDTA whole blood sample. Parameter specific SD and %CV were compared to those reported with normal levels of three lots of the CELL-DYN 22 Plus Control. Results from the whole blood run show that the precision attributes are comparable and parallel those of the three lots of the normal control with %CV values within acceptable limits.
Precision performance: Data was collected internally and at two external sites across seven different CELL-DYN Emerald 22 instruments with multiple operators using 3 lots of CELL-DYN 22 Plus Controls. The external sites performed 10 consecutive runs across two different instruments with separate vials of control from each lot. Internally, Streck ran 10 consecutive runs per lot across three instruments. The acceptance criteria is based on a compilation of the %CV for each measurand. All %CV values were within the acceptable threshold value as shown below,
| Measurand | Lot # 09210 | | | %CV | Lot # 09202 | | | %CV | Lot # 09189-1 | | | %CV |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Low | Nor | High | | Low | Nor | High | | Low | Nor | High | |
| WBC | 3.05 | 2.29 | 1.88 | 10 | 3.34 | 2.51 | 2.17 | 10 | 3.53 | 2.99 | 2.61 | 10 |
| RBC | 2.39 | 2.04 | 1.82 | 10 | 2.21 | 2.15 | 1.91 | 10 | 1.79 | 1.68 | 1.99 | 10 |
| HGB | 2.26 | 1.80 | 1.41 | 10 | 1.80 | 1.50 | 1.54 | 10 | 1.70 | 1.74 | 1.64 | 10 |
| HCT | 2.34 | 2.21 | 2.04 | 10 | 2.54 | 2.96 | 2.25 | 10 | 2.24 | 1.97 | 2.56 | 10 |
| MCV | 0.85 | 0.81 | 0.78 | 10 | 0.95 | 0.90 | 0.90 | 10 | 1.04 | 0.93 | 1.05 | 10 |
| MCH | 2.04 | 2.15 | 2.31 | 10 | 2.61 | 2.74 | 2.29 | 10 | 2.01 | 2.05 | 2.61 | 10 |
| MCHC | 2.53 | 2.71 | 2.80 | 10 | 3.28 | 3.44 | 2.96 | 10 | 2.79 | 2.72 | 3.33 | 10 |
| RDW | 3.73 | 3.53 | 2.34 | 10 | 3.42 | 2.95 | 2.26 | 10 | 3.10 | 3.76 | 2.40 | 10 |
| PLT | 11.30 | 5.58 | 3.74 | 15 | 11.05 | 5.17 | 3.73 | 10 | 9.66 | 5.30 | 3.97 | 10 |
| MPV | 3.07 | 2.05 | 1.76 | 10 | 3.08 | 2.78 | 2.06 | 10 | 3.12 | 2.99 | 2.10 | 10 |
| NEU% | 2.49 | 1.98 | 1.05 | 10 | 2.54 | 1.59 | 1.17 | 10 | 2.88 | 2.09 | 1.35 | 10 |
| NEU# | 3.92 | 3.18 | 2.22 | 10 | 4.35 | 2.75 | 2.57 | 10 | 4.90 | 3.58 | 2.68 | 10 |
| LYM% | 6.35 | 5.14 | 5.02 | 15 | 5.70 | 4.38 | 3.96 | 15 | 5.81 | 4.64 | 4.28 | 15 |
| LYM# | 7.60 | 5.89 | 4.92 | 15 | 6.91 | 4.53 | 3.74 | 15 | 6.15 | 4.92 | 4.12 | 15 |
| MON% | 8.57 | 5.87 | 5.01 | 20 | 8.18 | 7.17 | 4.71 | 20 | 10.54 | 8.45 | 4.89 | 20 |
| MON# | 13.53 | 7.96 | 6.12 | 20 | 11.39 | 8.93 | 6.18 | 20 | 12.39 | 9.78 | 6.03 | 20 |
| EOS% | 16.79 | 14.15 | 10.76 | N/A | 15.34 | 10.95 | 7.76 | N/A | 17.69 | 16.09 | 14.14 | N/A |
| EOS# | 26.57 | 16.26 | 12.27 | N/A | 35.51 | 19.45 | 9.11 | N/A | 38.33 | 18.03 | 17.14 | N/A |
| BAS% | 56.14 | 51.31 | 38.64 | N/A | 45.36 | 39.03 | 25.36 | N/A | 60.65 | 44.30 | 34.11 | N/A |
| BAS# | 120.35 | 50.26 | 43.66 | N/A | 188.13 | 72.78 | 32.64 | N/A | 99.16 | 63.51 | 38.70 | N/A |
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Value assignment: A minimum of three vials per level were tested on the CELL-DYN Emerald 22 instrument. Each vial was tested for a minimum of
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three test events on different dates, yielding a minimum of nine data points. Off-site laboratories ran each vial in duplicate consecutively generating a minimum of six data points. The data were entered into the validated QC link database program to calculate the mean, standard deviation, and coefficient of variation for each parameter analyzed. Final assay assignment values were determined using data collected and established product performance characteristics. Expected range values assigned to the assay were based on $\pm 3\mathrm{SD}$ of the assay data.
Open vial stability: The 8-day open vial stability claim was verified using three lots of the CELL-DYN 22 Plus Control. Each vial was mixed and opened daily to effectively simulate customer usage. Each level was tested using the CELL-DYN Emerald instrument on days 1 and 8, and a minimum of two intermediate time intervals.
Closed vial stability: A 75-day closed vial stability claim was verified using three lots of the CELL-DYN 22 Plus Control. Each level was tested using the CELL-DYN Emerald instrument at minimum every 14 days over a minimum period of 75 days.
The acceptance criteria for both open and closed vial stability is based on a compilation of the $\% \mathrm{CV}$ for each measurand over the data collected across 7 different CELL-DYN Emerald 22 instruments, at 3 sites, throughout the product dating claim. Reported $\% \mathrm{CV}$ for each measurand was within the threshold value $(< 10\% \mathrm{CV})$.
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:
Not applicable
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The end-user is instructed to refer to the product assay sheet accompanying the product information sheet.
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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.
5
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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.
