The sponsor conducted a Normal Population Study using 121 donor samples to establish and validate reference ranges for the hematology analyzer.
Reference Range Study; Donor samples; Clinical validation
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Normal Population Study; Observational study of donor samples
121 donors; Sample Size: 121
Not applicable for this study
Establishment of reference ranges for 13 hematology parameters
Indications for Use
The BC-3200 auto hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter to be used in clinical laboratories for In Vitro Diagnostic purpose. The intended use of BC-3200 Auto Hematology Analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.
Device Story
The BC-3200 is an automated hematology analyzer for clinical laboratory use by trained professionals. It processes whole blood samples (closed vial or prediluted) using automated sampling, diluting, and mixing. It employs two measurement methods: the Coulter method for WBC, RBC, and PLT counting/sizing, and a colorimetric method for HGB concentration. The system generates 16 hematology parameters and three histograms. Results are compared against user-defined normal ranges; the device flags abnormal results (H/L) for further clinical review. This automated analysis assists clinicians in patient screening and identifying samples requiring manual differential or additional diagnostic studies.
Clinical Evidence
No new clinical data was required for this submission. Analytical performance (accuracy, precision, linearity, carryover) was established under the previous clearance (k063407). The current submission focuses on software modifications to unmask four parameters (Mid%, Mid#, RDW, MPV) for QC reporting, supported by software validation and hazard analysis documentation.
Technological Characteristics
Automated hematology analyzer; Coulter impedance principle for WBC, RBC, PLT; colorimetric method for HGB. Dimensions/form factor: benchtop. Connectivity: computer-controlled with data storage/review. Reagents: M-30 series (diluent, rinse, lyse, cleansers). Standards: IEC61010-1, IEC61010-2-101, ISO14971, EN 13640, EN 591, EN 375, EN 980, IEC 61326.
Indications for Use
Indicated for use in clinical laboratories by trained medical professionals to perform quantitative automated hematology analysis and leukocyte differential counting on human blood samples to identify normal patients and flag results requiring further study.
Regulatory Classification
Identification
An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
Predicate Devices
COULTER® A⁶•T diff 2™ Analyzer (k990352)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k093394
B. Purpose for Submission:
To obtain clearance for unmasking of 4 previously shielded parameters of a cleared device (k063407)
C. Manufacturer and Instrument Name:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
BC-3200 Auto Hematology Analyzer
D. Type of Test or Tests Performed:
WBC, Lymph #, Mid#, Gran#, Lymph%, Mid%, Gran%, RBC, HGB, MCV, MCH, MCHC, RDW, HCT, MPV, WBC Histogram, RBC Histogram, and PLT Histogram
E. System Descriptions:
1. Device Description:
The BC-3200 Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic use in clinical laboratories. It consists of the analyzer, M-30 serial reagents (M-30D diluent, M-30CFL lyse, M-30R rinse, M-30E E-Z cleanser and M-30P probe cleanser), SC-CAL plus calibrators and BC-3D controls.
The BC-3200 Auto Hematology Analyzer is only to be used by trained medical professionals to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies. The analyzer provides analysis results of 16 parameter of human blood and three histograms.
2. Principles of Operation:
WBCs are counted and sized by the impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle, which in this case is a blood cell suspended in a conductive diluent as it passes through an aperture of known dimensions. HGB is determined by the colorimetric method. RBCs and PLTs are counted by the impedance method also. In addition, for RBCs and PLTs, volumetric metering is used. An accurate cell count cannot be obtained unless the precise volume of diluted sample that passes through the aperture during the count cycle is known. The analyzer uses a volumetric metering unit to control the count cycle and to ensure that a precise volume of sample is analyzed for the measurement.
3. Modes of Operation:
Closed Vial Whole Blood Mode, Whole Blood Mode for venous blood, and Predilute Mode for capillary blood.
4. Specimen Identification:
Barcode or manual keyboard entry.
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5. Specimen Sampling and Handling:
Samples are manually loaded into a sample compartment one at a time. The BC-3200 utilizes an automatic sampling and mixing device for sample processing. The Mindray calibrator is called SC-CAL PLUS.
6. Calibration:
The device has two calibration programs: manual calibration and auto calibration using commercial calibrators. The Mindray calibrator is called SC-CAL PLUS.
7. Quality Control:
The device has two QC programs: L-J Analysis and X-B Analysis. The Mindray three level control is called BC-3D)
8. Software:
All components of the device are controlled/monitored by software, which is responsible for the functionality, user interface, safety checks and performance accuracy.
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
☐ Yes ☑ X or No
F. Regulatory Information:
1. Regulation section:
21 CFR §864.5220: Automated Differential Cell Counter
2. Classification:
Class II
3. Product code:
GKZ: Counter, Differential Cell
4. Panel:
81 Hematology
G. Intended Use:
1. Indication(s) for Use:
The BC-3200 auto hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter to be used in clinical laboratories for In Vitro Diagnostic purpose.
The intended use of BC-3200 Auto Hematology Analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.
2. Special Conditions for Use Statement(s):
N/A
H. Substantial Equivalence Information:
1. Predicate Device Name(s) and 510(k) numbers:
COULTER® A⁶•T diff 2™ Analyzer, k990352
2. Comparison with Predicate Device:
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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | A quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories | Same |
| Sample Types | Whole Blood Mode and Prediluted Mode | Same |
| Sample Processing | Utilizes an automatic sampling, diluting, and mixing device for sample processing | Same |
| Calibration | 2 calibration programs: manual calibration and auto calibration using commercial calibrators | Same |
| Aperture Alert | Minimize the possibility of reporting erroneous results caused by a partial or transient aperture clog or by other aperture disturbance | Same |
| Display | LCD | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Operating Modes | Closed Vial Whole Blood Mode | Closed Vial Whole Blood Mode and Open Vial Whole Blood Mode |
| Throughput | 1 minute/analysis | 60 seconds or less for each sample |
| Quality Control | 2 QC programs: L-J Analysis and X-B Analysis | 1 QC program: L-J Analysis |
| Recommended Controls | BC-3D: Low, Normal, & High | 4C PLUS: Abnormal Low, Normal, Abnormal |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | High |
| Recommended Calibrator | CBC-CAL PLUS | S-CAL calibrator |
| Sample Volume Aspirated | 13 μL whole blood
20 μL prediluted blood | 18 μL whole blood
20 μL prediluted blood |
| Reagents Required | M-30D Diluent
M-30R Rinse
M-30CFL Lyse
M-30E E-Z Cleanser
M-30P Probe Cleanser | diff A^{C}-T Park or diff A^{C}-T Tain reagent park, both of which contain diluent and lytic reagent. A^{C}-T Rinse Shutdown Diluent |
| Parameters | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymph%, Lymph#, Mid%, Mid#, Gran%, Gran#, RDW, MPV | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Ly%, Ly#, MO%, MO#, GR%, GR#, RDW, MPV |
| WBC Operating Range | 0.0 - 299.9 (×10^{3}/μL) | 0.0 - 150 (×10^{3}/μL) |
| RBC Operating Range | 0.00 - 19.99 (×10^{6}/μL) | 0.00 - 8.00 (×10^{6}/μL) |
| HGB Operating Range | 0 - 29.9 (×g/dL) | 0.00 - 30.0 (×g/dL) |
| PLT Operating Range | 0 - 2999 (×10^{3}/μL) | 000 - 3000 (×10^{3}/μL) |
| MCV Operating Range | 0.0 - 249.9 fL | 50.0 - 130.0 fL |
I. Special Control/Guidance Document Referenced (if applicable):
1. ISO 14971: Standards Title Medical device - Application of Risk Management to Medical Devices. Version 2001/A1:2003.
2. IEC 61010-1: Standards Title Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirement. Version 2001.
3. IEC 61010-2-101: Standards Title Safety requirements for electrical equipment for measurement, control, and laboratory use -Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment. Version 2002.
4. IEC 61326: Standards Title Electrical equipment for measurement, control and laboratory use – EMC requirements. Version 2002.
5. EN 13640: Standards Title Stability testing of in vitro diagnostic medical devices. Version 2002.
6. EN 13612: Standards Title Performance evaluation of in vitro diagnostic medical devices. Version 2002.
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7. NCCLS EP5-A: Standards Title Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. Version 1999.
8. NCCLS EP9-A2: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (Second Edition). Version 2002.
9. NCCLS H20-A: Reference Leukocyte Differential (Proportional) and Evaluation of Instrumental Methods, Approved Standard. Version 1992.
## J. Performance Characteristics:
1. **Analytical Performance:**
a. **Accuracy:**
Established under k063407
b. **Precision/Reproducibility:**
Established under k063407
c. **Linearity:**
Established under k063407
d. **Carryover:**
Established under k063407
e. **Interfering Substances:**
The sponsor provided a list of commonly known interferences as supported by published references.
2. **Other Supportive Instrument Performance Data Not Covered Above:**
a. **Software Documentation:**
Modifications of the software that allow the sponsor to add the four parameters (i.e., Mid%, Mid#, RDW, MPV) to previously claimed 12 parameters for the BC-3D control and to add them at the QC screen have been sufficiently documented.
The sponsor has provided acceptable documentation demonstrating that the sponsor developed software for this device under an appropriate software development program; performed hazard analyses from both the patient's and user's standpoints, and addressed those hazards; and carried out an appropriate validation process. These procedures provide the foundation for assuring, to the extent possible, that the software will operate in a manner described in the specifications, and in no other way.
## K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
## L. 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.
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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.
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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.
