(93 days)
Not Found
No
The summary describes a chemical reagent for a standard laboratory test and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is an in vitro diagnostic reagent used to determine Activated Partial Thromboplastin Time (APTT) and related coagulation procedures, not to treat a condition.
Yes
This device is an in vitro diagnostic reagent used to determine Activated Partial Thromboplastin Time (APTT) in patient plasma for routine screening, which is a diagnostic procedure.
No
The device is a liquid reagent, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is "for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures" and "to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening...". This clearly indicates it is intended for use on biological samples (patient plasma) to provide information about a medical condition (coagulation deficiencies).
- Device Description: The description refers to it as an "in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays." The term "in vitro diagnostic reagent" is a direct indicator of its classification.
- Performance Studies: The document describes correlation studies and precision studies performed on patient samples (normal, abnormal, and lupus anticoagulant positive samples), which are typical evaluations for IVD devices.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease.
N/A
Intended Use / Indications for Use
The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.
Product codes
GGW
Device Description
R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.
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
Not Found
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
In correlation studies, APTT testing of normal and abnormal patients, as well as samples from patients positive for lupus anticoagulants were tested using both reagents. APTT testing at two sites and on two different instrument types vielded correlation coefficients of R = 0.92 (photo-optical), slope = 0.864 and R = 0.93 (mechanical), slope = 1.09. In addition correlation coefficients of R = 0.94 (photo-optical), slope = 0.866 and R = 0.99 (mechanical), slope = 0.627 were obtained for lupus anticoagulant positive samples. Within-run and between-run precision studies were also performed and CV's of less than 3% were obtained for the proposed device. CV's of less than 3% are also reported for the predicate device in the manufacturers directional insert. The Calcium Chloride products are identical in formulation of 0.025M Calcium Chloride.
Key Metrics
Correlation coefficients:
R = 0.92 (photo-optical), slope = 0.864
R = 0.93 (mechanical), slope = 1.09
R = 0.94 (photo-optical), slope = 0.866 (lupus anticoagulant positive samples)
R = 0.99 (mechanical), slope = 0.627 (lupus anticoagulant positive samples)
Precision: CV's of less than 3%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
0
Premarket Notification 510(k)KO3347 / Phospholin ES
FEB -- 4 2004
8.0 Premarket Notification 510(k) Summary
[As required by section 807.92(c)]
| Applicant: | Michael J. Morris
R2 Diagnostics, Inc.
412 South Lafayette Blvd.
South Bend, IN 46601
USA |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Peggy S. Carter
R2 Diagnostics, Inc.
412 South Lafayette Blvd.
South Bend, IN 46601
TEL: (574) 288-4377
FAX: (574) 288-2272 |
| Date: | October 22, 2003 |
| Trade Name: | R2 Diagnostics Phospholin ES |
| Common Name: | Activated Partial Thromboplastin Time |
| Classification Name: | Test, Time, Partial Thromboplastin
(per 21 CFR section 864.7925) |
| Comparison Device: | Dade Actin FSL, K863594
Stago Calcium Chloride |
Description of the Device and Intended Use
R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.
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Summary of Substantial Equivalence Comparisons
R2 Diagnostics Phospholin ES and Calcium Chloride are substantially equivalent in intended use and performance to Dade Actin FSL and Stago Calcium Chloride. Both the predicate device and the proposed product are formulated to detect deficiencies in factors II, V, VIII, IX, XI, and XII (APTT and APTT-based factor assays). Both reagents are also sensitive to lupus anticoagulants. In correlation studies, APTT testing of normal and abnormal patients, as well as samples from patients positive for lupus anticoagulants were tested using both reagents. APTT testing at two sites and on two different instrument types vielded correlation coefficients of R = 0.92 (photo-optical), slope = 0.864 and R = 0.93 (mechanical), slope = 1.09. In addition correlation coefficients of R = 0.94 (photo-optical), slope = 0.866 and R = 0.99 (mechanical), slope = 0.627 were obtained for lupus anticoagulant positive samples. Within-run and between-run precision studies were also performed and CV's of less than 3% were obtained for the proposed device. CV's of less than 3% are also reported for the predicate device in the manufacturers directional insert. The Calcium Chloride products are identical in formulation of 0.025M Calcium Chloride.
Conclusion: Substantial Equivalence Statement
In Summary, the identical intended use, similar technological characteristics and the performance data provided in this premarket notification demonstrate that R2 Phospholin ES and Calcium Chloride are substantially equivalent to Dade Actin FSL and Stago Calcium Chloride.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
FEB - 4 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Peggy Carter, Ph.D. Director, Product Development R2 Diagnostics, Inc. 412 S. Lafayette Boulevard South Bend, Indiana 46601
Re: K033471
Trade/Device Name: Phospholin ES and Calcium Chloride Regulation Number: 21 CFR § 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: II Product Code: GGW Dated: January 8, 2004 Received: January 14, 2004
Dear Dr. Carter:
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 dcvices 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 either 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 (QS) regulation (21 CFR Part 820). This letter 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.
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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Joseph L. Archellett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K033471
Device Name: Phospholin ES and Calcium Chloride
Indications for Use:
The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Kantzler
Division Sien-Of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k03347/
(Posted November 13, 2003)
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