(147 days)
No
The summary describes a mechanical system that simulates blood flow and measures platelet function based on closure time. There is no mention of AI, ML, image processing, or data-driven algorithms for analysis or interpretation.
No.
The device is designed to aid in the detection of platelet dysfunction, providing a tool to measure in vitro platelet function. It does not directly treat a condition or restore a bodily function, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" states, "To aid in the detection of platelet dysfunction in citrated human whole blood." The "Device Description" further clarifies it "provides a tool for clinicians to use in the detection of platelet dysfunction." These phrases clearly indicate a diagnostic purpose.
No
The device description explicitly states "The PFA-100® system provides a tool..." and "The PFA-100® system simulates...". This language, along with the description of simulating physical processes ("interaction of platelets with an injured blood vessel"), strongly suggests a hardware component is involved in the testing process, not just software for analysis or display. The predicate devices also refer to a "Platelet Function Analyzer," which is typically a physical instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "To aid in the detection of platelet dysfunction in citrated human whole blood." This indicates the device is used to analyze a biological sample (blood) outside of the body to provide information about a medical condition (platelet dysfunction).
- Device Description: The description further clarifies that the system "measures in vitro platelet function as related to primary hemostasis." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device uses "citrated human whole blood," which is a biological specimen.
- Purpose: The purpose is to aid in the detection of a medical condition (platelet dysfunction).
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dade® PFA-100® Platelet Function Analyzer and associated reagents are in vitro diagnostic devices intended to aid in the detection of platelet dysfunction in citrated human whole blood.
To aid in the detection of platelet dysfunction in citrated human whole blood.
Product codes
JOZ
Device Description
The PFA-100® system provides a tool for clinicians to use in the detection of platelet dysfunction induced by intrinsic platelet defects, von Willebrand factor (vWF) functional deficiencies, or exposure to platelet inhibiting agents. The PFA-100® system simulates, under high shear stress, the interaction of platelets with an injured blood vessel. These conditions allow the PFA-100® system to measure in vitro platelet function as related to primary hemostasis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Different studies conducted by independent organizations have shown results that suggest good performance of the system when testing pediatric populations and good assessment of DDAVP treatment.
A summary of the different studies used in support of this submission is included in this section.
Summary of New Literature Demonstrating PFA-100 System Performance in Pediatric Populations
| Attachment | Reference | Assay Used | Diagnosis | Results | No. of patients in study |
|---|---|---|---|---|---|
| 4 | Cariappa et al. | • Bleeding history | |||
| • Bleeding time | |||||
| • Aggregometry | |||||
| • Platelet count | |||||
| • PT | |||||
| • aPTT | |||||
| • VWF assays | |||||
| • Repeat testing after drug discontinuation | |||||
| • PFA-100 | • Platelet defects | PFA: | |||
| • Sensitivity | |||||
| o CEPI = 100% | |||||
| o CADP = 87% | |||||
| • Specificity | |||||
| o CEPI = 97% | |||||
| o CADP = 80% | |||||
| • Efficiency | |||||
| o CEPI = 98% | |||||
| o CADP = 83% | 52 | ||||
| • VWD | • Sensitivity | ||||
| o CEPI = 100% | |||||
| o CADP = 80% | |||||
| • Efficiency | |||||
| o CEPI = 98% | |||||
| o CADP = 80% | |||||
| 5 | Lippi et al. | • VWF:Ag | |||
| • PFA-100 | • Normal platelet function | PFA CT for CEPI and CADP not different in pediatric patients and normal adults | 52 |
Summary of Literature Demonstrating PFA-100 System Performance in Management of Bleeding Disorders
| Attachment | Reference | Assay Used | Therapy | Diagnosis | Results | No. of patients in study |
|---|---|---|---|---|---|---|
| 6 | Fressinaud et al. | • Bleeding history | ||||
| • Bleeding time | ||||||
| • Platelet count | ||||||
| • VWF:Ag | ||||||
| • VWF:RCo | ||||||
| • FVIII activity | ||||||
| • RIPA | ||||||
| • VWF multimers | ||||||
| • PFA-100 | • DDAVP | |||||
| • VWF concent. | Congenital VWD | PFA CT normalized in 23 Type I patients after DDAVP infusion | 41 (23 VWD Type I) | |||
| 7 | Koscielny et al. | • Platelet count | ||||
| • PT | ||||||
| • APTT | ||||||
| • PFA-100 | ||||||
| • Bleeding time | ||||||
| • VWF:Ag | ||||||
| • Aggregometry | ||||||
| • Flow cytometry | None | • VWD | ||||
| • Aspirin-induced platelet defect | ||||||
| • Other platelet defects | PFA Col/EPI CTs were prolonged in 250 of 256 (97.7%) patients with impaired hemostasis | 5649 | ||||
| 8 | Koscielny et al. | • Platelet count | ||||
| • PT | ||||||
| • APTT | ||||||
| • PFA-100 | ||||||
| • Bleeding time | ||||||
| • VWF:Ag | ||||||
| • Aggregometry | ||||||
| • Flow cytometry | • DDAVP | • VWD | ||||
| • Aspirin-induced platelet defect | ||||||
| • Other platelet defects | • PFA CTs normalized in 229 patients after DDAVP | |||||
| • Blood usage same in patients after DDAVP and those with normal hemostasis | 5649 (256 impaired hemostasis in prospective study) | |||||
| • None | • Blood usage 8X higher in patients with untreated abnormal hemostasis than in those with normal hemostasis | 5102 (317 impaired hemostasis in retrospective study) |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
o CEPI = 100%
o CADP = 87%
Specificity:
o CEPI = 97%
o CADP = 80%
Efficiency:
o CEPI = 98%
o CADP = 83%
Sensitivity:
o CEPI = 100%
o CADP = 80%
Efficiency:
o CEPI = 98%
o CADP = 80%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).
0
Kα60489
JUL 2 1 2006
510(k) Summary Dade® PFA-100® Platelet Function Analyzer Dade® PFA-100® Reagents
Manufacturer's Name, Address, Telephone, and Contact Person, 1. Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
35041 Marburg, Germany |
| --------------- | --------------------------------------------------------------------------------- |
|---|
| Contact Information: | Dade Behring Inc.
P.O. Box 6101
Newark, Delaware 19714
Attn: Radames Riesgo
Tel: 305.480.7558 |
| ---------------------- | ----------------------------------------------------------------------------------------------------------- |
|---|
Preparation date: July 11. 2006
2. Device Name/ Classification:
Dade® PFA-100® Platelet Function Analyzer and Dade® PFA-100® Reagents / Automated platelet aggregation systems, Class II (21 CFR § 864.5700)
3. ldentification of the Legally Marketed Device:
Dade® PFA-100® Platelet Function Analyzer (K970505 and K002885)
4. Device Description:
The PFA-100® system provides a tool for clinicians to use in the detection of platelet dysfunction induced by intrinsic platelet defects, von Willebrand factor (vWF) functional deficiencies, or exposure to platelet inhibiting agents. The PFA-100® system simulates, under high shear stress, the interaction of platelets with an injured blood vessel. These conditions allow the PFA-100® system to measure in vitro platelet function as related to primary hemostasis.
5. Device Intended Use:
The Dade® PFA-100® Platelet Function Analyzer and associated reagents are in vitro diagnostic devices intended to aid in the detection of platelet dysfunction in citrated human whole blood.
6. Medical device to which equivalence is claimed and comparison information:
The modified Dade® PFA-100® system is substantially equivalent in intended use and performance to the currently marketed Dade® PFA-1008 system.
1
7. Device Performance Characteristics:
Different studies conducted by independent organizations have shown results that suggest good performance of the system when testing pediatric populations and good assessment of DDAVP treatment.
A summary of the different studies used in support of this submission is included in this section.
Summary of New Literature Demonstrating PFA-100 System Performance in Pediatric Populations
| Attachment | Reference | Assay Used | Diagnosis | Results | No. of
patients in
study | |
|------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 4 | Cariappa et
al. | • Bleeding history
• Bleeding time
• Aggregometry
• Platelet count
• PT
• aPTT
• VWF assays
• Repeat testing
after drug
discontinuation
• PFA-100 | • Platelet
defects | PFA:
• Sensitivity
o CEPI = 100%
o CADP = 87%
• Specificity
o CEPI = 97%
o CADP = 80%
• Efficiency
o CEPI = 98%
o CADP = 83% | 52 | |
| | | | • VWD | • Sensitivity
o CEPI = 100%
o CADP = 80%
• Efficiency
o CEPI = 98%
o CADP = 80% | | |
| 5 | Lippi et al. | • VWF:Ag
• PFA-100 | • Normal
platelet
function | PFA CT for CEPI
and CADP not
different in
pediatric patients
and normal adults | 52 | |
| Attachment | Reference | Assay Used | Therapy | Diagnosis | Results | No. of
patients in
study |
| 6 | Fressinaud
et al. | • Bleeding
history
• Bleeding time
• Platelet count
• VWF:Ag
• VWF:RCo
• FVIII activity
• RIPA
• VWF
multimers
• PFA-100 | • DDAVP
• VWF
concent. | Congenital
VWD | PFA CT
normalized in 23
Type I patients
after DDAVP
infusion | 41
(23 VWD
Type I) |
| 7 | Koscielny
et al. | • Platelet count
• PT
• APTT
• PFA-100
• Bleeding time
• VWF:Ag
• Aggregometry
• Flow cytometry | None | • VWD
• Aspirin-
induced
platelet
defect
• Other
platelet
defects | PFA Col/EPI
CTs were
prolonged in 250
of 256 (97.7%)
patients with
impaired
hemostasis | 5649 |
| 8 | Koscielny
et al. | • Platelet count
• PT
• APTT
• PFA-100
• Bleeding time
• VWF:Ag
• Aggregometry
• Flow cytometry | • DDAVP | • VWD
• Aspirin-
induced
platelet
defect
• Other
platelet
defects | • PFA CTs
normalized in
229 patients
after DDAVP
• Blood usage
same in
patients after
DDAVP and
those with
normal
hemostasis | 5649 (256
impaired
hemostasis
in
prospective
study) |
| | | | • None | | • Blood usage
8X higher in
patients with
untreated
abnormal
hemostasis
than in those
with normal
hemostasis | 5102 (317
impaired
hemostasis
in
retrospective
study) |
2
Summary of Literature Demonstrating PFA-100 System
Performance in Management of Bleeding Disorders
3
Image /page/3/Picture/1 description: The image shows a black and white logo. The logo consists of a symbol resembling three curved lines or waves stacked on top of each other. This symbol is enclosed within a circular border of text. The text is small and difficult to read, but it appears to be arranged around the circumference of the circle.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
JUL 2 1 2006
Dade Behring, Inc c/o Radames Riesgo Regulatory Affairs & Compliance Manager Bldg 500, Mail Box 514 P.O. Box 6101 Newark, DE 19714-6101
Re: K060489
Trade/Device Name: Dade® PFA-100® Platelet Function Analyzer Dade® PFA-100® Reagents Regulation Number: 21 CFR 864.5700 Regulation Name: Automated Platelet Aggregation System Regulatory Class: Class II Product Code: JOZ Dated: 23 February 2006 Received: 24 February 2006
Dear Mr. Riesgo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter
4
Page 2 -
will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert H. Roffey
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K060489
Dade® PFA-100® Platelet Function Analyzer Device Name: Dade® PFA-100® Reagents
Indications for Use:
To aid in the detection of platelet dysfunction in citrated human whole blood.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Peter H. Ractery
Session Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
660487