The Emit® 2000 N-Acetylprocainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of N-Acetylprocainamide in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of N-Acetylprocainamide overdose or in monitoring levels of N-Acetylprocainamide to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

Device Description

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

AI/ML Overview

The provided text is a 510(k) summary for the Emit® 2000 N-Acetylprocainamide Assay, a diagnostic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, novel device might. The core of this submission is that the modified device is similar to an already approved predicate device, with minor packaging differences.

Therefore, the typical structure for reporting acceptance criteria and a study proving their achievement is not directly applicable in this context. The document emphasizes that the "modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." This implies that the performance characteristics (e.g., accuracy, precision, linearity) are expected to be the same as the predicate device, and the demonstration of substantial equivalence serves as the "proof."

However, I can extract information related to what would be considered "performance" in such a context, even if the detailed study results aren't explicitly provided in this summary.

Here's an attempt to answer your questions based on the provided text, acknowledging its limitations:

Acceptance Criteria and Study for Emit® 2000 N-Acetylprocainamide Assay

Based on the provided 510(k) summary (K011620), the primary "acceptance criteria" for the modified Emit® 2000 N-Acetylprocainamide Assay relate to its substantial equivalence to an existing predicate device. The underlying assumption is that the predicate device's performance already meets established clinical and analytical requirements. The study here essentially demonstrates that the minor changes (packaging, bottle size, barcode) do not negatively impact the assay's performance characteristics.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for a modified device emphasizing substantial equivalence due to minor packaging changes, explicit quantitative acceptance criteria for primary diagnostic metrics (e.g., sensitivity, specificity, accuracy) are not detailed in this summary for the modified device. Instead, the "performance" demonstrated is that the re-packaged device maintains the "same assay performance characteristics" as the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Device	The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. Minor differences in packaging (smaller fill volume, wedge-shaped bottles, barcode).
Compatibility with specified OLYMPUS® analyzers	The modified reagent bottles are compatible with OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
(Presumed Analytical Performance: Sensitivity, Specificity, etc.)	(Implicitly, these are assumed to be identical to the predicate device and meet acceptable analytical standards. Specific data not provided in summary.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The 510(k) summary does not provide specific details about the sample size, type (e.g., patient samples vs. spiked controls), or provenance of a test set used to explicitly re-evaluate performance characteristics for this modified device. The declaration of "same assay performance characteristics" suggests that validation was performed, but the specifics are not included in this high-level summary. Given the nature of a chemical assay, it would typically involve prospective testing with controlled samples or clinical specimens.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. For an in vitro diagnostic assay like this (measuring N-Acetylprocainamide levels), "ground truth" is established through highly accurate reference methods or clinical outcomes, not typically by expert consensus of imaging or pathology. The determination of N-Acetylprocainamide levels is an objective measurement.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring human adjudication of results in the conventional sense (e.g., for image interpretation). Analytical measurements are typically verified against established standards or validated reference methods.

5. 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 is an automated immunoassay, not a device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

This is a standalone algorithm/device. The Emit® 2000 N-Acetylprocainamide Assay is an automated immunoassay system (reagents used on OLYMPUS® analyzers) that quantitatively measures N-Acetylprocainamide. Its performance is entirely determined by the chemical reaction and instrument measurement, without human interpretive input affecting the fundamental result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For an in vitro diagnostic test measuring a specific analyte, "ground truth" (or analytical true value) is typically established by:

Reference Methods: Highly accurate and precise analytical methods (e.g., GC-MS, HPLC) that are considered the gold standard.
Certified Reference Materials: Solutions with known, certified concentrations of the analyte.
Interlaboratory Comparisons: Though less about "ground truth" and more about comparative performance.

While not explicitly stated in the summary, given it's an assay for N-Acetylprocainamide, the ground truth would have been established using one or a combination of these analytical approaches.

8. The sample size for the training set

Not applicable. This is a chemical immunoassay, not a machine learning or AI-based device that typically requires a "training set" in the computational sense. The "training" of the assay system itself comes from its chemical design and optimization steps during development, and calibration against known standards.

9. How the ground truth for the training set was established

Not applicable, as there isn't a "training set" in the machine learning sense. The assay's analytical performance (linearity, precision, accuracy) is calibrated and validated using reference materials or samples with known, analytically determined concentrations (as described in point 7).

Summary

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K0 11620

JUN 1 8 2001

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® 2000 N-Acetylprocainamide Assay

1. Manufacturer and Contact Information:

Manufacturer:

Syva Company - Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014

Contact Information:

Cynthia Arredondo Requlatory Affairs Syva Company - Dade Behring, Inc. 3403 Yerba Buena Road San Jose, CA 95135 Tel: 408 - 239 - 2671 Fax: 408 - 239 - 2348

Date Summary Prepared: 2. May 24, 2001

3. Device Trade Name:

Emit® 2000 N-Acetylprocainamide Assay

4. Common Name:

Enzyme Immunoassay, N-Acetylprocainamide

5. Device Classification Name:

The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "N-Acetylprocainamide test system" as Class II, 21 CFR Part 862. 3450.

6. Intended Use:

7. Device Description:

8. Substantial Equivalence

The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. In conclusion the modified Emit® 2000 N-Acety|procainamide Assay is substantially equivalent to the predicate Emit® 2000 N-AcetyIprocainamide Assay.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is drawn with thick, curved lines, giving it a modern and abstract appearance.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 8 2001

Ms. Cynthia Arredondo Regulatory Affairs Syva Company - Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95135

510(K) Number: K011620 Re: Trade/Device Name: Emit® 2000 N-Acetylprocainamide Assay Regulation Number: 862.3450 Regulatory Class: II Product Code: LAN Dated: May 24, 2001 Received: May 25, 2001

Dear Ms. Arredondo:

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 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). 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 (Premarket Approval), 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 895. A 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 regulation (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 action. In addition, FDA may publish further announcements 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 regulations.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket This icitication. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri inding of bassification 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 CFF Part 801 and If you desire specific acrise to jiagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This chargestions on the promotion and advertising of your device, (301) 594-4586. predac one of the orelov creference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsibilities as a mober (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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Indications for Use Statement

Device Name: Emit® 2000 N-Acetylprocainamide Assay 510(k) Number (if known): Koll620

Indications for Use:

Fred Lacy

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K011620

510(k) Number.

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3320 Digoxin test system.

(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.