(50 days)
Not Found
No
The device description and performance studies focus on mechanical detection of clot formation and standard statistical analysis, with no mention of AI or ML algorithms.
No
The device is described as a diagnostic test for monitoring heparin anticoagulation, not for treating a disease or condition. It is explicitly stated as "For In Vitro Diagnostic Use Only".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation" and "For In Vitro Diagnostic Use Only," which are key indicators of a diagnostic device.
No
The device description clearly outlines a physical test cuvette with dried reagents and an instrument that draws blood, pumps it, and uses LEDs to detect blood motion and clot formation. This involves significant hardware components and chemical reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use Only".
- Nature of the Test: The device performs a quantitative one-stage Activated Partial Thromboplastin Time (APTT) test using a citrated whole blood sample. This is a laboratory test performed on a biological sample outside of the body to diagnose or monitor a medical condition (in this case, heparin anticoagulation).
- Device Description: The description details a "self-contained disposable test cuvette, pre-filled with dried reagents" and an instrument that analyzes the blood sample and detects a clot. This is consistent with the components of an in vitro diagnostic system.
Therefore, based on the provided text, the Hemochron Jr. Citrate APTT is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the Hemochron Jr. microcoagulation instruments. The test is intended for use in point of care settings. For In Vitro Diagnostic Use Only
Product codes
GFO
Device Description
The Hemochron Jr.Citrate APTT test is a self-contained disposable test cuvette, pre-filled with dried reagents required to perform an Activated Partial Thromboplastin Time (APTT) using citrated whole blood in the Hemochron Jr. Whole Blood Microcoagulation Analyzers. The preparation consists of kaolin, phospholipid, stabilizers and buffers. These same components are used in the previous formulation of the citrate APTT. The citrate APTT test can be performed on both the Hemochron Jr. II and Hemochron Jr. Signature Series instruments. The test is intended for point of care use. The instrument draws a precise volume of blood into the test channel of the The mountient contains the APTT reagent formulation. An array of LED's detects the motion of the blood sample/reagent mixtures as it moves through the precision the modon of the orood campler. The blood is pumped back and forth until a clot begins to form, obstructing the channel and slowing the flow of the blood sample. The instrument detects a clot when the blood movement decreases below a predetermined rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
point of care settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The laboratory correlation was generated using fresh citrated blood samples (n=210) from patients undergoing catheterization and angioplasty. Samples were analyzed at the patient bedside using the "modified" Hemochron Jr. Citrate APTT. An aliquot of at the pattern bousine with sodium citrate, centrifuged and plasma was sent to a the sumple was mined will be these a PTT test was performed on each sample collected using Dade Actin FSL* APTT reagent on an Electra 900 MLA instrument.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory Correlation:
- Study Type: Clinical correlation study.
- Sample Size: 210 fresh citrated blood samples.
- Key Results: The Hemochron Jr. APTT plasma equivalent values were highly correlated to the laboratory plasma citrate APTT values (R=0.88) with a correlation equation of y=0.77x+8.57.
In House Precision Testing:
- Study Type: Precision study.
- Sample Size: Multiple citrate APTT tests performed using two preparations (normal donors and patients receiving heparin anticoagulant). Two different lots of Citrate APTT test cuvettes were used, and testing was performed on three separate days.
- Key Results:
- Cuvette Lot 1 (Normal): Mean (sec) ranges from 86-95, SD (sec) ranges from 2.1-6.5, CV (%) ranges from 2.3-6.9. Total N=9, Mean=91, SD=5.9, CV=6.4.
- Cuvette Lot 2 (Normal): Mean (sec) ranges from 90-99, SD (sec) ranges from 1.0-6.1, CV (%) ranges from 1.1-6.8. Total N=9, Mean=95, SD=5.8, CV=6.1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (R) = 0.88
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image contains the word "INTERNATIONAL" in all capital letters. The text is written in a simple, sans-serif font. The letters are black, and the background is white.
TECHNIDYN CORPORATION Phone: (732) 548-5700 FAX: (732) 632-9299
510 (k) Summary
Hemochron® Jr. Citrate Activate Partial Thromboplastin Time (APTT) Cuvette
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _K014 008
November 29, 2001 Prepared:
John Clay Submitted by: International Technidyne Corp. 6 Olsen Ave. Edison, NJ 08820 (732-548-2325) Fax (732-548-5700) Ext. 265
Device Name
| Common / Usual Name: | Activated Partial Thromboplastin Time |
|---|---|
| Product Name: | Hemochron® Jr. Citrate APTT Cuvette |
Predicate Device
The "modified" Hemochron Jr. Citrate APTT, which is the subject of this special 510(k) is a modification of the predicate Hemochron Jr. Citrate APTT, which was cleared under K972831.
Device Description and Technological Characteristics
The Hemochron Jr.Citrate APTT test is a self-contained disposable test cuvette, pre-filled with dried reagents required to perform an Activated Partial Thromboplastin Time (APTT) using citrated whole blood in the Hemochron Jr. Whole Blood Microcoagulation Analyzers. The preparation consists of kaolin, phospholipid, stabilizers and buffers. These same components are used in the previous formulation of the citrate APTT. The citrate APTT test can be performed on both the Hemochron Jr. II and Hemochron Jr. Signature Series instruments. The test is intended for point of care use.
1
The instrument draws a precise volume of blood into the test channel of the The mountient contains the APTT reagent formulation. An array of LED's detects the motion of the blood sample/reagent mixtures as it moves through the precision the modon of the orood campler. The blood is pumped back and forth until a clot begins to form, obstructing the channel and slowing the flow of the blood sample. The instrument detects a clot when the blood movement decreases below a predetermined rate.
Modifications to the Predicate Hemochron Jr Citrate APTT Cuvette
Formulation
The only modification to the citrate APTT cuvette is to the reagent formulation, The only invention would the phospholipid concentration and the reduction spoonnoan'y, are open of calcium salts required for re-calcification of the citrated whole blood sample. The modification to the formula improves the correlation to the laboratory APTT Plasma result when either 3.2% or 3.8% sodium citrate tubes are used for the blood sample collection.
The modifications to the Citrate APTT described herein do not change the indications for use or the fundamental technology used in the previously cleared system.
Statement of Intended Use
The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the Hemochron Jr. microcoagulation instruments. The test is intended for use in point of care settings.
For In Vitro Diagnostic Use Only
Summary of Performance Data and Precision
The laboratory correlation was generated using fresh citrated blood samples (n=210) from patients undergoing catheterization and angioplasty. Samples were analyzed at the patient bedside using the "modified" Hemochron Jr. Citrate APTT. An aliquot of at the pattern bousine with sodium citrate, centrifuged and plasma was sent to a the sumple was mined will be these a PTT test was performed on each sample collected using Dade Actin FSL* APTT reagent on an Electra 900 MLA instrument.
2
Additional clinical studies were conducted to confirm the correlation to the laboratory result. The Hemochron Jr. APTT plasma equivalent values were highly correlated to the laboratory plasma citrate APTT values (R=0.88) with a correlation equation of v=0.77x+8.57.
In House Precision Testing
Precision testing was evaluated by performing multiple citrate APTT tests using two I receision tooning was on on on on on on preparations, which have been selected to represent normal donors (Level I) and patients receiving heparin anticoagulant (Level II). Two different lots of Citrate APTT test cuvettes were used in the precision study and testing was performed on three separate days.
PRECISION DATA
Cuvette Lot 1
| Normal | |||||
|---|---|---|---|---|---|
| N | Mean | ||||
| (sec) | SD | ||||
| (sec) | CV | ||||
| (%) | N | ||||
| Day 1 | 3 | 95 | 6.5 | 6.9 | 3 |
| Day 2 | 3 | 92 | 2.1 | 2.3 | 3 |
| Day 3 | 3 | 86 | 5.0 | 5.9 | 3 |
| Total | 9 | 91 | 5.9 | 6.4 | 9 |
| Cuvette Lot 2 | |||||
| Normal | |||||
| N | Mean | ||||
| (sec) | SD | ||||
| (sec) | CV | ||||
| (%) | N | ||||
| Day 1 | 3 | 94 | 1.0 | 1.1 | 3 |
| Day 2 | 3 | 99 | 5.9 | 5.9 | 3 |
| Day 3 | 3 | 90 | 6.1 | 6.8 | 3 |
| Total | 9 | 95 | 5.8 | 6.1 | 9 |
Conclusion
The technology employed and intended use of the modified Hemochron Jr.Citrate APTT cuvette is substantially equivalent to the Predicate Hemochron Jr. Citrate APTT. This modification to the formula improves the correlation to the laboratory APTT Plasma result when either 3.2% or 3.8% sodium citrate tubes are used for the blood sample collection.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. John Clay Regulatory Affairs Manager ITC. Inc. 8 Olsen Avenue Edison, NJ 08820
JAN 2 4 2002
Re: K014008
Trade/Device Name: Hemochron® Jr. Citrate APTT cuvette Regulation Number: 21 CFR 864.7925 Regulation Name: Partial thromboplastin time tests Regulatory Class: Class II Product Code: GFO Dated: January 16, 2002 Received: January 17, 2002
Dear Mr. Clay:
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 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/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
5
510(k) Number (If Known):
Device Name: Hemochron® Jr. Citrate APTT cuvette Indications for Use:
The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the Hemochron Jr. microcoagulation instruments. The test is intended for use in point of care settings.
For In Vitro Diagnostic Use Only
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jasmine Bautista
(Division Sign-Off)
Clinical Laboratory Devices
510(k) number K0114008
Prescription Use
Per 21 CFR 801.109
✓
or
Over- the- Counter Use
(Optional Format 1-2-96)