ACTIVE RENIN IRMA MODEL NUMBER DSL-25100

• K Number: K981607
• Device Name: ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
• Manufacturer: DIAGNOSTIC SYSTEMS LABORATORIES, INC.
• Date Cleared: 1998-05-27 ( 22 days)
• Product Code: CIB
• Regulation Number: 862.1085
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of active renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.

Device Description

The DSL 25100 ACTIVE™ Renin Coated Tube IRMA Kit was developed for the quantitative measurement of active renin in human serum or plasma. This Coated Tube IRMA format is a capture assay. Anti-human renin mouse monoclonal antibody to renin is immobilized to the surface of the coated bead. Renin in the standards or samples is "sandwiched" between this monoclonal antibody and the anti-human Renin mouse monoclonal antibody radiolabeled for detection with I-125.

AI/ML Overview

The DSL ACTIVE™ Renin Coated Tube IRMA kit was evaluated for its substantial equivalence to the Nichols Diagnostics ACTIVE Renin IRMA. The study involved comparing the results from both assays on patient samples to establish this equivalence.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Substantial Equivalence: Demonstrated through linear regression analysis and correlation coefficient comparing against the predicate device.	Linear Regression Equation: Y = 0.94(X) - 5.3
	Correlation Coefficient (r): 0.94

Note: The document implicitly defines substantial equivalence based on a high correlation and a linear relationship between the new device and the predicate device's measurements. Specific thresholds for the slope, intercept, or correlation coefficient for "acceptance" are not explicitly stated as numerical criteria, but the reported values were deemed sufficient for substantial equivalence by the FDA.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 53 patient samples
• Data Provenance: The document states "patient samples were collected." No specific country of origin is mentioned, but the submitting company is based in Webster, Texas, USA. The data is retrospective in the sense that samples were collected and then assayed simultaneously by both methods, rather than being collected solely for future study. The samples were chosen based on expected Renin levels (low, intermediate, and high) to ensure a representative range.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There were no independent experts used to establish a new ground truth. Instead, the Nichols Diagnostics ACTIVE Renin IRMA served as the reference method, or "ground truth," for comparison. The performance of this predicate device itself would have been established through prior studies.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) was used for the test set. The comparison was direct between the new device and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted, as this device is an in vitro diagnostic (IVD) kit for quantitative measurement and does not involve human reader interpretation in the same way imaging devices might. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This study is a standalone performance evaluation of the device (the kit itself), comparing its results directly to a predicate device. There is no "human-in-the-loop" aspect to the device's function or the comparative study described.

7. Type of Ground Truth Used

The "ground truth" for the test set was the results obtained from the Nichols Diagnostics ACTIVE Renin IRMA, which served as the predicate device and the reference standard for comparison. This is a form of comparative ground truth against an established and legally marketed device.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. The 53 patient samples were used for the comparative clinical study to demonstrate substantial equivalence, which is typically a validation or test set in the context of device approval. If a training phase was involved in the development of the DSL ACTIVE™ Renin Coated Tube IRMA kit, that information is not provided in this summary.

9. How the Ground Truth for the Training Set Was Established

Since a dedicated training set is not explicitly mentioned, the method for establishing its ground truth is also not provided. For IVDs like this, the "training" (development and optimization) often involves internal testing against characterized samples or reference materials, which would have their values established through validated reference methods or inter-laboratory comparisons, but these details are not part of this 510(k) summary.

Summary

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445 Medical Center Soulevard Webster Texas 77598-4217 USA Tel [phone] Fax [phone]

Comments of

MAY 27 1998

K981607

Customer Assistance Center Tel [phone] Fax [phone] Email [e-mail]

SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: Classification Name: Analyte Name: Regulatory Class:

DSL 25100 ACTIVE™ Renin Coated Tube IRMA Kit Immunoradiometric Assay, Renin Renin

• John Class Submitter: Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: [phone]
  May 4, 1998 Date:

The DSL ACTIVE™ Renin Coated Tube IRMA kit was developed for the quantitative measurement of active renin in human serum or plasma. This Coated Tube IRMA format is a capture assay. Anti-human renin mouse monoclonal antibody to renin is immobilized to the surface of the coated bead. Renin in the standards or samples is "sandwiched" between this monoclonal antibody and the anti-human Renin mouse monoclonal antibody radiolabeled for detection with I-125.

The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of active renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.

The DSL ACTIVE™ Renin Coated Tube IRMA is substantially equivalent to the Nichols Diagnostics ACTIVE Renin IRMA. Both kits have the same intended use.

To demonstrate substantial equivalence between the two assays, patient samples (n = 53) were collected and assayed simultaneously by both methods. Samples were chosen based on expected Renin levels so those samples with low, intermediate and high levels of Renin would be evaluated. Linear regression analysis of the results obtained for the comparison with the Renin assay gave the equation Y =0.94(X) - 5.3 with a correlation coefficient of (r) = 0.94.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 27 1998

John Class . Manager of Regulatory Affairs Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598

Re : K981607 ACTIVE™ Renin IRMA Requlatory Class: II Product Code: CIB Dated: April 30, 1998 Received: May 5, 1998

Dear Mr. Class:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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

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Charles of the county of the county of the county of the county of Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel [phone] Fax [phone]

Customer Assistance Center Tel [phone] Fax [phone] Email [e-mail]

510(k) Number (if known):

Device Name: ACTIVE™ Renin Coated Tube IRMA Kit

Indications For Use:

DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative The determination of Renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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(Division Sign-Off)
Division of Clinical Laboratory Devices, C

Division of Clinical Labora 510(k) Number

Regulation Number and Section

§ 862.1085 Angiotensin I and renin test system.

(a)
Identification. An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.(b)
Classification. Class II.