(27 days)
Not Found
No
The 510(k) summary describes a quality control kit for a blood analysis system, consisting of control materials in syringes. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The description focuses on the chemical composition and packaging of the control materials.
No
This product is a creatinine control kit used for quality control assays on a blood analysis system, not for direct therapeutic intervention. It is classified for "in vitro Diagnostic Use Only."
No
The device is a control kit used to monitor the performance of a blood analysis system, not to directly diagnose a patient's condition.
No
The device description clearly states that the device is a "Creatinine Control Kit" which includes physical components like "control materials," "syringes," and "pouches." This indicates it is a hardware-based device, not software-only.
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".
- Purpose: The device is a control kit used to perform Quality Control assays for Creatinine on a blood analysis system. This means it's used to verify the accuracy and performance of an instrument that analyzes biological samples (blood) outside of the body. This is a core function of an IVD.
- Device Description: The description details a control material used for monitoring the performance of an analyzer, which is consistent with the role of an IVD control.
Therefore, based on the provided information, the IRMA TRUpoint™ Creatinine Control Kit is an IVD.
N/A
Intended Use / Indications for Use
The IRMA TRUpoint™ Creatinine Control Kit (CR Control Kit) (074402) are assayed quality control materials and are intended to be used to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System.
For in vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
75JJX
Device Description
The Creatinine Control Kit includes creatinine control materials at two levels for monitoring the IRMA analyzer performance at different points in the range of intended clinical utility. The control materials are packaged in capped luer lock syringes, each containing 1.5 ml of solution. The syringes are in turn packaged in pouches. Three (3) pouches/syringes for low level and three (3) pouches/syringes for high level are packaged in a box. The Cr control is an aqueous based solution of creatinine and sucrose. This control contains no human or biological materials.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
International Technidyne Corporation 510(k) Submission IRMA TRUpoint™ Creatinine Control
April 15, 2005
510(k) Summary
MAY 1 6 2005
Submitter Information
International Technidyne Corporation 2656 Patton Rd. Roseville, MN 55113 (800) 949-4762
Establishment Registration Number: 2183953
Contact: Nancy Ring Date Prepared: 4/15/05
Device Information
| Proprietary Name: | The IRMA TRUpoint™ Creatinine Control Kit |
|---|---|
| Common Name: | Creatinine Controls |
| Classification | (21 CFR 862.1660) |
| Classification Name: | Single Analyte Controls (Assayed and Unassayed) |
| Device Class: | I |
| Panel: | Chemistry |
| Product Code: | 75JJX |
Predicate Device
Substantial equivalence is claimed to the currently marketed Bionostics Inc. RNA 823 Controls (K943754) and Medical Analysis Systems' Moni-Trol H Controls (K030942).
Description of Device
The Creatinine Control Kit includes creatinine control materials at two levels for monitoring the IRMA analyzer performance at different points in the range of intended clinical utility. The control materials are packaged in capped luer lock syringes, each containing 1.5 ml of solution. The syringes are in turn packaged in pouches. Three (3) pouches/syringes for low level and three (3) pouches/syringes for high level are packaged in a box. The Cr control is an aqueous based solution of creatinine and sucrose. This control contains no human or biological materials.
Intended Use:
The IRMA TRUpoint™ Creatinine Control Kit (CR Control Kit) (074402) are assayed quality control materials and are intended to be used to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System.
For in vitro Diagnostic Use.
1
Technological Comparison to Predicate
The IRMA TRUpoint™ Creatinine Control Kit is comprised of materials in the same form and aqueous matrix as the predicate device, Bionostics Inc. RNA 823 Controls (K943754), both perform quality control assays, and both are stored at 2°C - 8°C. The IRMA TRUpoint™ Creatinine Control contains only creatinine while the Bionostics RNA QC 823 is a multi-analyte control without creatinine.
The IRMA TRUpoint™ Creatinine Control Kit is comprised of materials in the same form as the predicate device, Medical Analysis Systems Moni-Trol H (K030942). Both are used to perform quality controls assays and contain creatinine. The IRMA TRUpoint™ Creatinine Control contains only creatinine and is aqueous based whereas the Medical Analysis Systems Moni-Trol-H is a multi-analyte control, human serum based, and is stored at -20 ℃ until expiration date.
Substantial Equivalence Conclusion Summary
The IRMA TRUpoint™ Creatinine Control Kit is substantially equivalent to Bionostic's RNA QC 823 Blood gas, Electrolyte, Metabolite, and BUN control (K943754) and to Medical Analysis Systems Moni-Trol H (K030942) currently in commercial distribution. Both predicates have a similar intended use and are in a liquid form. The RNA QC823 control has a similar aqueous base and storage conditions. The Medical Analysis Systems Moni-Trol H is for the control of a similar analyte, creatinine.
The evaluations demonstrate that the IRMA TRUpoint™ Creatinine Control is substantially equivalent to the legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines representing the staff and two curved shapes representing the snakes.
MAY 1 6 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Ring OA/RA Manager International Technidyne Corp. 2656 Patton Road Roseville, MN 55113
Re: K050983
Trade/Device Name: IRMA TRUpoint™ Creatinine Control Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: April 15, 2005 Received: April 19, 2005
Dear Ms. Ring:
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 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).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter with anon. The FDA finding of substantial equivalence of your device to a legally premained notification ' '1 l 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, If you destre specific infortion 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 v Itto Diagnoutiled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may of and 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/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K050983
Device Name: IRMA TRUpoint™ Creatinine Control Kit
Indications for Use:
The IRMA TRUpoint™ Creatinine Control Kit is for use on the IRMA TRUpoint™ Blood Analysis System to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System.
For in vitro Diagnostic Use Only
Allo Sulin
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050983
XX Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
Division Sign-