Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells).
Device Story
Liquichek Hematology-16 Control LV is an assayed quality control material used to monitor the precision of hematology analyzers. It consists of a suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells, and animal-derived constituents in a stabilizing medium. The device is provided in 1.5 mL glass vials with screw caps. It is used in clinical laboratory settings by technicians or laboratory staff to verify the performance of hematology analyzers by comparing measured values against assigned ranges. The control is stored at 2°C to 8°C, with a shelf life of 160 days and an open-vial stability of 21 days. By providing an objective assessment of instrument precision, it helps ensure the reliability of patient blood cell counts and indices.
Clinical Evidence
No clinical data. Bench testing performed per CLSI EP5-A2 guidelines. Precision study conducted over 20 days (two runs/day, duplicate) across three levels of control. Total precision standard deviations were compared to instrument manufacturer claims using chi-square tests; all p-values were > 0.05, indicating no statistically significant difference in precision performance.
Technological Characteristics
Suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells, and animal-derived constituents in a stabilizing medium. 1.5 mL glass vials with screw caps. Storage: 2°C to 8°C. Shelf life: 160 days. Open vial stability: 21 days. Standard referenced: CLSI EP5-A2.
Indications for Use
Indicated for use as an assayed hematology control to monitor the precision of hematology analyzers measuring blood cell parameters (GRAN, HCT, HGB, LYMPH, MCH, MCHC, MCV, MID, MONO, MPV, PLT, RBC, RDW, WBC). No specific patient population or contraindications described.
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
Liquichek Hematology-16 Control (formerly known as TRI-COUNT 16) (k902389)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k091303
B. Purpose for Submission:
Modification of a cleared device
C. Measurand:
WBC, LYMPH, MONO, MID, GRAN, RBC, HGB, HCT, MCH, MCHC, MCV, RDW, PLT and MPV
D. Type of Test:
Assayed quality control material
E. Applicant:
Bio-Rad Laboratories
F. Proprietary and Established Names:
Liquichek Hematology-16 Control LV
G. Regulatory Information:
1. Regulation section:
21 CFR 864.8625; Hematology quality control
2. Classification:
Class II
3. Product code:
JPK; Mixture, Hematology Quality Control
4. Panel:
Hematology 81
H. Intended Use:
1. Intended use(s):
Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells).
2. Indication(s) for use:
Same as intended use
3. Special conditions for use statement(s):
Not applicable
4. Special instrument requirements:
Not applicable
I. Device Description:
This product is a suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells and constituents of animal origin in a medium containing stabilizers.
J. Substantial Equivalence Information:
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1. Predicate device name(s):
Liquichek Hematology-16 Control (formerly known as TRI-COUNT 16)
2. Predicate 510(k) number(s):
k902389
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells). | Liquichek Hematology-16 Control is a hematology reference control used in monitoring determinations of blood cell values on cell counters. |
| Form | Liquid | Same |
| Matrix | Suspension containing blood cells | Same |
| Preservatives | Contains preservatives | Same |
| Storage (unopened) | 160 days at 2°C to 8°C | Same |
| Open vial claim | 21 days at 2°C to 8°C | Same |
| Analytes | GRAN (Granulocytes), HCT (Hematocrit), HGB (hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (mid-Sized Cells)/ Mono (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC (Red Blood Cells), RDW (Red Blood Cells Distribution Width), WBC (White Blood Cells) | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Fill Volume | 1.5 mL | 3.0 mL |
| Vial Type | Glass vials with screw caps | Glass tubes with pierceable caps |
# K. Standard/Guidance Document Referenced (if applicable):
CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods
L. Test Principle:
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The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. Three levels of control are available to allow monitoring of performance.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Each level of control was tested two times per day, in duplicate, for 20 days as outlined in the CSLI EP5-A2 guideline. The total precision standard deviations for Liquichek Hematology-16 Control LV (Table 1) were compared to the instrument manufacturer precision standard deviation (Table 2) and the statistical p-values were calculated utilizing a chi-square test. The observed differences between the study precision results and the instrument manufacturer precision claims are considered statistically significant when the p-values are < 0.05. The p-values obtained from this study are > 0.05 (Table 3), which indicates that the observed differences are not statistically significant.
Table 1: Total precision standard deviation for Liquicheck Hematology-16 Control LV
| Parameter | RBC Cells/μL | Hbg g/dL | MCV fL | RDW % | PLT Cells/μL | MPV fL | WBC Cells/μL | LY% | MO% | GR% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Low | 0.025 | 0.076 | 0.542 | 0.198 | 1.654 | 0.124 | 0.096 | 1.243 | 1.206 | 0.946 |
| Normal | 0.027 | 0.103 | 0.502 | 0.153 | 4.861 | 0.062 | 0.133 | 1.066 | 0.906 | 0.794 |
| High | 0.029 | 0.116 | 0.560 | 0.309 | 11.089 | 0.075 | 0.227 | 0.643 | 0.382 | 0.756 |
Table 2: Instrument Manufacturer Precision Standard Deviation
| Parameter | RBC Cells/μL | Hbg g/dL | MCV fL | RDW % | PLT Cells/μL | MPV fL | WBC Cells/μL | LY% | MO% | GR% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Low | 0.040 | 0.120 | 0.720 | 0.348 | 3.780 | 0.198 | 0.170 | 2.964 | 1.136 | 1.500 |
| Normal | 0.040 | 0.120 | 0.720 | 0.318 | 9.900 | 0.198 | 0.170 | 2.438 | 0.100 | 2.138 |
| High | 0.042 | 0.140 | 0.768 | 0.322 | 17.435 | 0.198 | 0.362 | 2.059 | 0.100 | 2.707 |
Table 3: Statistical "p" Values for Total Precision SD
| Parameter | RBC Cells/μL | Hbg g/dL | MCV fL | RDW % | PLT Cells/μL | MPV fL | WBC Cells/μL | LY% | MO% | GR% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Low | 1.0000 | 1.0000 | 0.9818 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 0.2247 | 1.0000 |
| Normal | 0.9998 | 0.9499 | 0.9976 | 1.0000 | 1.0000 | 1.0000 | 0.9985 | 1.0000 | 0.1925 | 1.0000 |
| High | 0.9997 | 0.9841 | 0.9931 | 0.6311 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 0.9864 | 1.0000 |
b. Linearity/assay reportable range:
Not Applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Stability studies were performed to determine the open vial and shelf life
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stability for the Liquichek Hematology-16 Control LV. Two lots of data are provided for each study. These studies are performed in such a manner as to mimic the handling of product in the customer's hands following opening of these products and their preparation for use. The open vial study time is typically defined to be at least 20% longer than the claimed open vial stability for the product and tested at least at four time points: at the beginning at the end and two time points during the middle of the study (T-zero, T-M1, T-M2 and T-Final + 20%). The acceptance criterion is generally defined as the T-Final + 20% being within the expected ranges.
Open Vial Stability: All parameters are stable for 21 days when stored at 2°-8°C.
Shelf life stability: All parameters are stable for 160 days at 2 -8° C.
The review of the data was within acceptable limits.
Value Assignment: The mean values printed in the Liquichek Hematology-16 Control LV package insert are derived from replicate analyses and are specific for each lot of product. The tests listed are performed by manufacturer or independent laboratories using a representative sampling of each product.
Laboratory results may vary from the listed values. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation calibrating methods, reagents or by any stated limitations for this product. It is recommended that each laboratory establish its own means and acceptable ranges with each lot of Liquichek Hematology-16 Control LV.
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:
Expected values are provided in the Package Insert accompanying the product.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
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O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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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
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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.
