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

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.

AI/ML Overview

The provided document is a 510(k) summary for the IRMA TRUpoint™ Creatinine Control Kit. This submission is for a quality control material intended to monitor the performance of an analyzer, not for a diagnostic device that measures patient analytes directly. Therefore, the concepts of sensitivity, specificity, or diagnostic accuracy as typically applied to medical devices for patient diagnosis or screening do not apply in the same way.

The "acceptance criteria" for a quality control material generally relate to its stability, consistency, and ability to generate expected values when tested on the intended analyzer. The study presented here is a demonstration of substantial equivalence to existing legally marketed predicate devices, rather than a performance study with traditional clinical acceptance criteria.

Here's an interpretation based on the provided text, aligning with the spirit of the request by describing the implicit "acceptance criteria" for a QC device and how the submission addresses them:

Acceptance Criteria and Device Performance for a Quality Control Material (Derived from Substantial Equivalence)

For a Quality Control material like the IRMA TRUpoint™ Creatinine Control Kit, the "acceptance criteria" are implicitly met if the device demonstrates substantial equivalence to predicate devices. This means it performs its intended function (monitoring analyzer performance) in a comparable manner, considering its form, matrix, intended use, and storage conditions.

Acceptance Criteria (Implied for QC Material Substantial Equivalence)	Reported Device Performance
Similar Intended Use:	The IRMA TRUpoint™ Creatinine Control Kit is "intended to be used to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System." This intended use is comparable to predicate devices which also "perform quality control assays" for analytes.
Similar Form and Matrix:	The device is "comprised of materials in the same form and aqueous matrix" as the Bionostics Inc. RNA 823 Controls (K943754). It is also in "the same form" as Medical Analysis Systems Moni-Trol H (K030942), though the latter is human serum based, while the IRMA TRUpoint™ Creatinine Control is aqueous.
Similar Analyte Control:	The IRMA TRUpoint™ Creatinine Control contains only creatinine. One predicate, Medical Analysis Systems Moni-Trol H, is explicitly stated to be "for the control of a similar analyte, creatinine." While the other predicate (Bionostics RNA QC 823) is a multi-analyte control without creatinine, the overall substantial equivalence claim encompasses the specific analyte being controlled.
Comparable Storage Conditions:	The IRMA TRUpoint™ Creatinine Control and the Bionostics Inc. RNA 823 Controls are both stored at 2°C - 8°C. The Medical Analysis Systems Moni-Trol H has different storage conditions (-20°C). However, the overall substantial equivalence argument considers the composite similarities.
Safety and Effectiveness (implicitly similar):	By demonstrating substantial equivalence to legally marketed devices, it is inferred that the new device shares similar safety and effectiveness profiles for its intended function as a quality control material. Unlike patient-contact devices, the primary "safety" here relates to stable, reliable control values and lack of biohazards (explicitly stated: "This control contains no human or biological materials"). "Effectiveness" relates to its ability to perform the QC function.

Study Details (Based on the 510(k) Summary)

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicates rather than presenting de novo clinical study data with detailed performance metrics. Therefore, many of the requested details about specific study design (e.g., sample sizes, ground truth establishment, expert adjudication) are not applicable or not explicitly provided for this type of submission.

Here's an attempt to address the points based solely on the provided text, indicating when information is not available:

A table of acceptance criteria and the reported device performance:
- Addressed in the table above. The "acceptance criteria" are implied by the requirements for substantial equivalence. The "reported device performance" is the claim of substantial equivalence based on the comparisons made.
Sample size used for the test set and the data provenance:
- Not explicitly provided. This submission describes the device and compares its technical characteristics to predicates to establish substantial equivalence. It does not detail specific performance testing data (e.g., precision, accuracy, stability studies) that would typically involve a "test set" in the context of diagnostic accuracy. While such studies would have been performed by the manufacturer, the 510(k) summary focuses on the comparative argument.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. For a quality control material, "ground truth" isn't established by experts in the same way it would be for a diagnostic image or pathology slide. The "truth" for a QC material is its known concentration of the analyte, which is verified through analytical methods. The submission doesn't detail the analytical validation process for the control itself, only its comparison to predicates.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication is relevant for subjective assessments (e.g., human reader interpretations). This is a technical comparison for a quality control material, not a diagnostic interpretation study.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This submission is for a quality control material, not an AI or imaging diagnostic device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a quality control material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated/Not applicable in the human-centric sense. For a quality control material, the "ground truth" would be the assigned value or target value for creatinine, determined through highly accurate reference methods or inter-laboratory consensus, which the control material is manufactured to. The document does not detail how these target values were established for the IRMA TRUpoint™ Creatinine Control Kit, but focuses on its equivalence in form and function to other marketed QC materials.
The sample size for the training set:
- Not applicable. This is a physical quality control material, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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International Technidyne Corporation 510(k) Submission IRMA TRUpoint™ Creatinine Control

April 15, 2005

K050983

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

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.

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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.

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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).

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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

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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-

Regulation Number and Section

§ 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.