The intended use of the Sysmex® CA-500 Series is as a compact, fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument uses citrated human plasma to perform the following parameters and calculated parameters: Clotting Analysis Parameters - Prothrombin Time (PT) . - Activated Partial Thromboplastin Time (APTT) . - Fibrinogen (Clauss) . - Thrombin Time . Chromogenic Analysis Parameters - Antithrombin III ● Calculated Parameters - PT Ratio . - PT INR . - Derived Fibrinogen .
Device Story
Sysmex CA-500 is a compact, fully automated, computerized blood plasma coagulation analyzer for clinical laboratory use. Device processes citrated human plasma samples to perform clotting and chromogenic assays. Principle of operation involves automated analysis of coagulation parameters; system calculates PT Ratio, PT INR, and Derived Fibrinogen. Healthcare providers use output to assess patient coagulation status and manage pathological conditions. Device benefits include automated, high-throughput testing compared to manual methods, providing rapid, standardized results for clinical decision-making.
Clinical Evidence
Bench testing only. Comparative performance evaluation conducted against the predicate CA-6000 analyzer using 104-131 samples per assay. Results demonstrated high correlation (r values ranging from 0.806 to 0.997) across Prothrombin Time, APTT, Fibrinogen, Thrombin Time, and Antithrombin III assays.
Technological Characteristics
Compact, fully automated, computerized coagulation analyzer. Uses citrated human plasma. Performs clotting and chromogenic analysis. Connectivity and specific material standards not detailed. Software-controlled automated processing.
Indications for Use
Indicated for in vitro diagnostic use in clinical laboratories to perform coagulation and chromogenic analysis on citrated human plasma samples. Parameters include PT, APTT, Fibrinogen (Clauss), Thrombin Time, and Antithrombin III, plus calculated PT Ratio, PT INR, and Derived Fibrinogen.
Regulatory Classification
Identification
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Special Controls
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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SEP 3 0 1998
# Premarket Notification 510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-500
510K
Summo
Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125
i.
Contact Person: Radames Riesgo at 305.636.7727 or by facsimile at 305.637.6887.
Trade or Proprietary Name: Sysmex® Automated Coagulation Analyzer CA-500
Common or Usual Name: Automated Coagulation Instruments
Classification Name:
Coagulation instrument (21 CFR §864.5400)
Registration Number:
Manufacturing Site TOA Medical Electronics Co. Kobe. Japan
7010360
1981711
Importer Sysmex™ Corporation of America Gilmer Road 6699 RFD Long Grove, IL 60047-9596
1422681
Distributor Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125
1017272
The CA-500 is substantially equivalent in intended use and technological characteristics to its predecessor, the CA-6000 analyzer. Both instruments are manufactured by TOA Medical Electronics, CO, Ltd., Kobe, Japan. The CA-6000 analyzer was described in details under Document Control No. K964139. The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.
Data to support substantial equivalence to the predicate device were generated during correlation studies performed in house. In these studies, comparative performance evaluations were conducted using the proposed device and the predicate device to evaluate specimens from apparently healthy individuals and from patients with different pathological conditions which are
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510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-500 Page 2
100 100
expected to affect the results for a particular assay. The following summary shows the results of the comparison between the proposed and the predicate devices.
్ నిర్మా ఇతర ప్ర
| Test | Sample<br>Number<br>(n) | Coefficient of<br>Correlation<br>(r) | Regression<br>Equation |
|-------------------------------------------------------------|-------------------------|--------------------------------------|------------------------|
| Prothrombin Time<br>(Dade® Innovin®, seconds) | 111 | 0.991 | Y = 0.98X + 0.3 |
| Prothrombin Time<br>(Dade® Innovin®, INR) | 111 | 0.991 | Y = 0.99X + 0.03 |
| Derived Fibrinogen<br>(Dade® Innovin®) | 104 | 0.983 | Y = 0.78X + 31.2 |
| Prothrombin Time<br>(Dade® Thromboplastin C Plus, seconds) | 131 | 0.997 | Y = 1.00X + 0.02 |
| Prothrombin Time<br>(Dade® Thromboplastin C Plus, INR) | 131 | 0.997 | Y = 1.00X + 0.01 |
| Derived Fibrinogen<br>(Dade® Thromboplastin C Plus) | 131 | 0.979 | Y = 0.92X + 20.2 |
| Prothrombin Time<br>(Thromborel® S, seconds) | 119 | 0.990 | Y = 0.99X + 0.2 |
| Prothrombin Time<br>(Thromborel® S, INR) | 119 | 0.989 | Y = 1.00X + 0.01 |
| Derived Fibrinogen<br>(Thromborel® S) | 115 | 0.985 | Y = 0.86X + 29.2 |
| Activated Partial Thromboplastin Time<br>(Dade® Actin®) | 114 | 0.997 | Y = 1.00X - 0.3 |
| Activated Partial Thromboplastin Time<br>(Dade® Actin® FSL) | 116 | 0.997 | Y = 1.01 X - 0.01 |
| Activated Partial Thromboplastin Time<br>(Pathromtin® SL) | 114 | 0.996 | Y = 0.98X + 1.0 |
| Fibrinogen (Clauss) | 119 | 0.989 | Y = 0.95X + 20.3 |
| Thrombin Time | 128 | 0.806 | Y = 0.54X + 9.8 |
| Antithrombin III | 109 | 0.927 | Y = 0.91X + 10.8 |
### Summary of Method Comparison Studies between CA-500 and CA-6000
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## PREMARKET NOTIFICATION THFUL AND ACCURATE STATEMEN [As Required by 21 CFR 807.87(j)]
I certify that, in my capacity as manager of Hemostasis Systems Integration of Dade Behring Inc., I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
William M. Hoover
Manager, Systems Integration
15 May 1998
Date
K981711 Premarket Notification Number
*Must be signed by a responsible person of the firm required to submit the premarket notification (e.g., not a consultant for the 510(k) submitter).
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2098 Gaither Road Rockville MD 20850
Food and Drug Administration
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
# SEP 3 0 1998
Mr. Radames Riesgo Manager Regulatory Affairs DADE Behring, Inc. P.O. Box 520672 Miami, Florida 33152-0672
Re : K981711/S1
> Trade Name: Sysmex® Automated Coaqulation Analyzer CA-500 Requlatory Class: II Product Code: JPA Dated: September 4, 1998 Received: September 8, 1998
Dear Mr. Riesgo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. . Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K981711 510(k) Number (if known):
Revis.
Find to
Use
Device Name: Sysmex® Automated Coagulation Analyzer CA-500
### Indications For Use:
The intended use of the Sysmex® CA-500 Series is as a compact, fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. I a
The instrument uses citrated human plasma to perform the following parameters and calculated parameters:
Clotting Analysis Parameters
- Prothrombin Time (PT) .
- Activated Partial Thromboplastin Time (APTT) .
- Fibrinogen (Clauss) .
- Thrombin Time .
Chromogenic Analysis Parameters
- Antithrombin III ●
Calculated Parameters
- PT Ratio .
- PT INR .
- Derived Fibrinogen .
(PLEASE DO NOT WITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rur E. Mahon
nru Dannou
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
00108
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.
