The Vitalab c .- Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of a-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Device Description

The Vitalab a-Amylase Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines amylase through the cleavage of 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNP-a-G3) to produce 2-chloro-4-nitrophenol.

AI/ML Overview

This document describes the acceptance criteria and the study that demonstrates the Vitalab α-Amylase Reagent meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria values are provided in the document for each performance parameter. However, the study's reported performance serves as the basis for demonstrating its suitability and equivalence to the predicate device.

Performance Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Vitalab α-Amylase Reagent)
Usable Range (Linearity)	Linearity over a specified range with high correlation to dilution factors.	Default sample volume: Linear range of 5 to 1,600 U/L. Recoveries = 0 U/L + 131 x (Dilution Factor), r = 0.9999, syx = 7.2 U/L.
		Rerun sample volume: Linear range of 1,200 to 3,200 U/L. Recoveries = 0 U/L + 133 x (Dilution Factor), r = 0.9999, syx = 17 U/L.
Detection Limit	A detection limit demonstrating the ability to accurately measure low concentrations.	0.4 U/L (mean + 2SD of repetitive assay of normal saline; 30 replicates, mean 0.3 U/L, SD 1.8 U/L).
Precision (Within-run and Total)	Acceptable levels of imprecision (low %CV) for various serum concentrations.	Default Mode:
		Serum 1 (98 U/L): 1SD = 1.0, %CV = 1.0% (within-run); 1SD = 1.5, %CV = 1.5% (total)
		Serum 2 (565 U/L): 1SD = 3.6, %CV = 0.6% (within-run); 1SD = 5.0, %CV = 0.9% (total)
		Serum 3 (1,034 U/L): 1SD = 7.0, %CV = 0.7% (within-run); 1SD = 9.7, %CV = 0.9% (total)
		Rerun Mode:
		Serum 1 (1,961 U/L): 1SD = 17, %CV = 0.9% (within-run); 1SD = 25, %CV = 1.3% (total)
		Serum 2 (2,517 U/L): 1SD = 26, %CV = 1.0% (within-run); 1SD = 41, %CV = 1.6% (total)
		Serum 3 (3,002 U/L): 1SD = 40, %CV = 1.3% (within-run); 1SD = 50, %CV = 1.7% (total)
Correlation with Predicate Device	Strong correlation with a legally marketed predicate device, indicated by a regression equation close to y=x and a low sy.x.	Selectra = -6 U/L + 1.086 x Competitive Reagent, sy.x = 4.0 U/L.
Stability (Onboard Reagent)	Reagent stability for a specified period with minimal change in performance.	14-day onboard stability, with total imprecision estimates less than 2 U/L or 1.2% for all controls.

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

Linearity (Usable Range):
- Default sample volume: n = 28 (number of recovery solutions/dilution factors)
- Rerun sample volume: n = 60 (number of recovery solutions/dilution factors)
Detection Limit: 30 replicates of normal saline.
Precision: 60 replicates for each of the 6 serum samples tested (3 in default mode, 3 in rerun mode).
Correlation: n = 120 mixed serum and plasma specimens. The document states these were "collected from adult patients", but the country of origin is not specified. The study appears to be retrospective, as specimens were "assayed" and then compared.
Stability: Not explicitly stated, but involved the assay of "serum controls" over the 14-day period.

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

Not applicable. This is an in vitro diagnostic device for measuring α-amylase levels, not an imaging or diagnostic algorithm requiring expert interpretation for ground truth. The "ground truth" for the performance studies is based on established analytical methods and reference ranges for the analyte.

4. Adjudication Method for the Test Set

Not applicable, as this is a quantitative chemical assay, not an interpretive diagnostic device.

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 in vitro diagnostic reagent, not an AI-assisted diagnostic tool requiring human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance evaluations of the Vitalab α-Amylase Reagent operating on the Vitalab Selectra Analyzer. The device directly produces quantitative results for α-amylase.

7. The Type of Ground Truth Used

Linearity: Based on theoretical dilution factors and measured recovery values, with the assumption that serial dilutions accurately represent the true concentration.
Detection Limit: Statistical calculation from repeated measurements of a blank (normal saline).
Precision: Defined by the variability of repeated measurements of control sera with known concentrations.
Correlation: The "ground truth" for correlation was the measurement obtained from a "commercially available method" (predicate device: Roche α-Amylase EPS ver.2 Reagent). This is a comparative study against an established predicate, rather than an absolute ground truth from pathology or outcomes.
Stability: Measured against the initial performance of the reagent and accepted analytical variation limits.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in the conventional sense. The development of the reagent and its optimization would have involved internal R&D, but not a formally defined "training set" for an algorithm.

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

Not applicable, as explained in point 8.

Summary

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K040534

Brea, CA 92821 T (714) 672-3553 F (714) 672-3554

Summary of 510(k) Safety and Effectiveness Information Vitalab a-Amylase Reagent

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitted by:

	Clinical Data, Inc.1075 West Lambert Road, Building DBrea, California 92861
Contact Person:	Wynn Stocking	Regulatory Affairs Manager

January 21, 2003 Date Submitted:

Device Names:

Proprietary name:	Vitalab Amylase Reagent
Common name:	Amylase reagent
Classification Name:	Catalytic methods, amylase

Device Description:

Intended Use:

The Vitalab ot-Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of a-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Predicate Device:

Roche a-Amylase EPS ver.2 Reagent, product no. 03183742, which is currently marketed by Roche Diagnostics Corp. of Indianapolis, IN

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Summary of Performance Data:

Usable Range: The linear range of the Vitalab α-Amylase Reagent is 5 to 1,600 U/L using the default sample volumeand 1,200 to 3,200 U/L using the reduced sample volume in rerun mode. The recoveries of linearityrelated solutions that span the linear range are compared to dilution factors using least squaresregression, which is forced through the origin.
Default sample volume(Vitalab Recoveries) = 0 U/L + 131 x (Dilution Factor), r = 0.9999, syx = 7.2 U/L, n = 28
Rerun sample volume(Vitalab Recoveries) = 0 U/L + 133 x (Dilution Factor), r = 0.9999, syx = 17 U/L, n = 60
Detection Limit: The detection limit is shown through the repetitive assay of normal saline. The observed mean andstandard deviation of a 30 replicate run are 0.3 and 1.8 U/L respectively. The detection limit,calculated as the mean plus two standard deviations of the recovery values, is 0.4 U/L.
Precision:	Precision is demonstrated by the replicate assay of control serum. Precision statistics, calculatedanalogous to the method described in NCCLS Guideline EP3-T, are shown below.
	Sample	n	mean	1SD	%CV	1SD	%CV
	Default
	Serum 1	60	98	1.0	1.0%	1.5	1.5%
	Serum 2	60	565	3.6	0.6%	5.0	0.9%
	Serum 3	60	1,034	7.0	0.7%	9.7	0.9%
	Rerun
	Serum 1	60	1,961	17	0.9%	25	1.3%
	Serum 2	60	2,517	26	1.0%	41	1.6%
	Serum 3	60	3,002	40	1.3%	50	1.7%
Correlation:	Mixed serum and plasma specimens, collected from adult patients, were assayed for α-amylase usingthe Vitalab Selectra E Analyzer and another commercially available method. Results were comparedby Deming regression and the following statistics were obtained.
	Selectra = -6 U/L + 1.086 x Competitive Reagentsy.x = 4.0 U/L n = 120 range = 26 - 1049 U/L
Stability:	The 14 day onboard reagent stability claim is documented through the assay of serum controls over theclaimed period. The statistical estimates of total imprecision are less than 2 U/L or 1.2% for allcontrols

. . . .

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 1 2004

Clinical Data, Inc. c/o: Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548

Re: K040534 Trade/Device Name: Vitalab a-Amylase Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ Dated: March 2, 2004 Received: March 2, 2004

Dcar Mr. Devine:

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 docs 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.

Sincerely vours.

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. 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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510(k) Number (if known):

K040534

Device Name:

Vitalab a-Amylase Reagent

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K040534

Prescription Use
(Per 21 CFR 801.109) √

ાર

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1070 Amylase test system.

(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.