LogoCoagulate
CGA-7 Hemostasis Analyzer · Now Shipping

Every Second of Hemostasis,
Measured.

The Coagulate CGA-7 delivers complete platelet aggregation profiles from 50 µL whole blood in under 8 minutes — real-time curves on a 7″ capacitive touchscreen, zero reagent prep.

CGA-7 · Live Analysis · Channel A
REC
100%75%50%25%0%
ADP 10µMPeak: 87%
87%peak
Aggregation
42sec
Lag Time
3.2%/min
Slope
50µL
Sample Vol
Scroll to evaluate
Technical Specifications

What's the sample volume?

50 µL. Less than a single drop. The CGA-7 runs a complete 6-agonist panel from a standard citrated tube — no preprocessing, no centrifugation.

50
µL sample
Industry min: 200 µL
< 8 min
Complete Profile
From sample load to printed report
4-ch
Simultaneous
Run 4 patients concurrently
6
Agonist Panel
ADP, Collagen, Epi, AA, Risto, TRAP-6
Complete Technical Parameters — CGA-7 Rev 3.1
Sample Volume50 µL whole blood (no anticoagulant prep)
Sample TypeCitrated whole blood, PRP, PPP
Throughput12 tests/hour (simultaneous 4-channel)
Analysis Time< 8 min per complete aggregation profile
Agonist PanelADP, Collagen, Epinephrine, Arachidonic Acid, Ristocetin, TRAP-6
Display7″ IPS capacitive touchscreen, 1280 × 800 px
Measurement Range0 – 100% aggregation (± 1.5% accuracy)
Temperature Control37°C ± 0.1°C (Peltier-controlled cuvette block)
Data OutputPDF, CSV, HL7 v2.5, FHIR R4, ASTM E1394
ConnectivityEthernet (RJ-45), USB-A ×2, RS-232
Power100–240 V AC, 50/60 Hz, 85 W max
Dimensions (W×D×H)320 × 280 × 195 mm
Weight5.8 kg (12.8 lbs)
Operating Environment15–30°C, 20–80% RH non-condensing
Reagent StorageOnboard 4°C refrigerated compartment (8-slot)
Internal Memory50,000 patient records, 10-year retention

* Specifications subject to change. Contact your regional applications specialist for configuration-specific data sheets. Rev 3.1 · Released 2026-01-15 · Doc# CGA7-TS-031

LIS / HIS Integration

How does it integrate with our LIS?

Bidirectional HL7 v2.5 and FHIR R4 out of the box. The CGA-7 ships with pre-built interface profiles for the 8 most common laboratory information systems — typical go-live is one business day, not a six-week IT project.

HL7 v2.5FHIR R4ASTM E1394LIS-2-A2POCT1-A2TCP/IPRS-232
Validated LIS Interfaces
Epic Beaker
Cerner PathNet
Sunquest LIS
SCC Soft Computer
Meditech Expanse
Orchard Harvest
Sysmex WAM
Roper iLab
Custom interface development available — typical 3-week turnaround
Workflow — Sample to Result
Step 1
Phlebotomist
Draws standard 2.7 mL citrate tube
Step 2
Sample Load
Place tube in CGA-7 — auto-detects barcode
Step 3
Auto-Analysis
6-agonist panel runs; real-time curves render
Step 4
LIS Transmission
HL7 ORU^R01 sent to your LIS in < 2 sec
Step 5
Verified Result
Tech reviews, approves, report auto-routes
Total TAT (Turnaround Time)
< 12 minutes
Phlebotomy to verified LIS result
Service & Maintenance

What are the maintenance intervals?

Preventive maintenance is designed around the lab tech's shift — not the FSE's calendar. Daily QC takes 8 minutes. The 6-month PM is the only task that requires a service call, and it can be performed remotely in 94% of cases.

Preventive Maintenance Schedule
IntervalTaskTimeBy
DailyQC run with Coag-Check control set8 minLab tech
WeeklyCuvette block cleaning + optical calibration15 minLab tech
MonthlyReagent inventory audit + stirring motor check20 minLab tech
6-MonthFull PM by certified FSE (remote or on-site)45 minFSE
AnnualCalibration verification + firmware update90 minFSE
94%
PMs completed remotely
99.2%
Fleet uptime (trailing 24 mo)
< 4 hr
Mean time to restore (MTTR)
3 yr
Mean time between failures
Service Agreement Tiers
Essential
Included 1 yr
Uptime SLA95%
Response4-hour remote
On-site2 business days
PM VisitsAnnual FSE visit
Most Selected
Professional
$2,400/yr
Uptime SLA99%
Response2-hour remote
On-siteNext business day
PM VisitsSemi-annual FSE
Enterprise
Contact sales
Uptime SLA99.9%
Response30-min remote
On-site4-hour on-site
PM VisitsQuarterly FSE
Regulatory & Compliance

Is it FDA 510(k) cleared?

Yes. Cleared under K241892, September 2024. The full decision summary and substantial equivalence documentation are available for download — formatted for procurement package submission.

FDA 510(k)
K241892
Cleared

Platelet aggregation analyzer, in vitro diagnostic

Cleared: September 12, 2024

Download clearance documentation
CE Mark
CE 2797
Active

IVD Directive 98/79/EC · Annex II List B

Valid through: December 2027

Download clearance documentation
ISO 13485
QMS-2024-0047
Certified

Design, manufacture, and service of IVD devices

Certified: March 2024 · BSI Group

Download clearance documentation
CAP / CLIA
CAP-2024-PLT
Active

Proficiency testing program participant · CLIA waived

Survey cycle: Q1 2026

Download clearance documentation
Standards Compliance
IEC 61010-1:2010 (Electrical safety)
IEC 61326-1:2012 (EMC — lab equipment)
ISO 15189:2022 (Medical laboratory quality)
CLSI H58-A (Platelet function testing)
CLSI EP05-A3 (Precision evaluation)
CLSI EP09-A3 (Method comparison)
CLSI EP15-A3 (User verification)
HIPAA Technical Safeguards (data at rest + transit)
For biomedical engineers writing procurement specs:

The CGA-7 technical file includes full IEC 60601-1 safety test reports, EMC test data, software validation documentation (IEC 62304), and risk management file (ISO 14971). Request the complete regulatory package via your regional sales engineer.

Competitive Analysis

How does it compare?

Side-by-side against the two analyzers most commonly on procurement shortlists. Data from published specifications and independent lab evaluations, Q4 2025.

Parameter
Coagulate CGA-7Our Analyzer
Competitor ACompetitor B
Sample Volume
50 µL
200 µL175 µL
Analysis Time
< 8 min
15–20 min12–18 min
Simultaneous Channels
4
22
Touchscreen Display
7″ IPS
None4.3″ TFT
LIS Protocols
HL7, FHIR, ASTM
HL7 onlyHL7, ASTM
Onboard Refrigeration
Yes (4°C)
NoNo
Remote PM
94% capable
40% capable55% capable
Agonist Channels
6 standard
4 standard5 standard
Footprint
320×280 mm
280×260 mm310×295 mm
FDA Cleared
Yes (K241892)
YesYes

Competitor data sourced from publicly available specifications. Competitor names withheld per industry practice. Full comparison report available on request.

−59% TAT
"We cut platelet function TAT from 22 minutes to under 9. The hematology team stopped calling the lab to check on results."
Dr. Rachel Kim
Lab Director, Midwest Regional Medical Center
50 µL
"The 50 µL sample volume was the deciding factor. Our pediatric unit draws are small — every other analyzer was off the table."
Marcus Osei
Chief of Hematology, Children's Hospital at Stanford
< 1 day LIS go-live
"Our biomedical team had the LIS interface live by 3 PM on installation day. That never happens with capital equipment."
Jennifer Hartley
Biomedical Engineering Director, Northside Health System

Ready to bring it to committee?

Request a demo unit for a 30-day clinical evaluation in your lab. No commitment, full technical support, and a turnkey procurement package ready for your purchasing committee.

Demo units ship within 5 business days · Full applications support included

Coagulate CGA-7
50 µL · 4-channel · FDA 510(k) K241892