STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) by ALKO DIAGNOSTIC CORP.

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation. The ALKO Standard Reagents are intended to serve as direct replacements to like named products manufactured by Dade Chemistry Systems Inc.(formally Dupont International). ALKO uses a similar composition, description and packaging design as that used by Dade Chemistry Systems Inc. in its products.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, structured to address your specific questions about acceptance criteria and study details:

Acceptance Criteria and Device Performance for ALKO Standards A, B, and C

This 510(k) submission describes ALKO Standards A, B, and C, intended for calibrating Na+, K+, Cl-, and TCO2 analytes on Dade Dimension Chemistry Systems with the MultiPLY™ Integrated Multisensor module. The study aims to demonstrate performance equivalence of ALKO products to Dade Chemistry Systems products.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria for the precision or accuracy studies in a tabular format. However, based on the presented data and the nature of calibration standards, implicit acceptance criteria can be inferred, primarily alignment with the performance of the predicate device (Dade Standards) and generally acceptable precision for diagnostic assays.

Implicit Acceptance Criteria and Reported Performance:

Study Type	Analyte	Implicit Acceptance Criteria (Inferred)	Reported Performance (from study data)
Precision	Na+ (Level 1)	CV% and STD within acceptable limits for diagnostic assays.	Total CV%: 1.0149%; Run to Run CV%: 0.6269% (STD: 1.2285, 0.7588)
	Na+ (Level 2)	CV% and STD within acceptable limits for diagnostic assays.	Total CV%: 0.5677%; Run to Run CV%: 0.4084% (STD: 1.0217, 0.7350)
	K+ (Level 1)	CV% and STD within acceptable limits for diagnostic assays.	Total CV%: 1.8308%; Run to Run CV%: 1.2328% (STD: 0.0494, 0.0333)
	K+ (Level 2)	CV% and STD within acceptable limits for diagnostic assays.	Total CV%: 0.8393%; Run to Run CV%: 0.5595% (STD: 0.0542, 0.0361)
	Cl- (Level 1)	CV% and STD within acceptable limits for diagnostic assays.	Total CV%: 0.6367%; Run to Run CV%: 0.4062% (STD: 0.4999, 0.3189)
	Cl- (Level 2)	CV% and STD within acceptable limits for diagnostic assays.	Total CV%: 0.5032%; Run to Run CV%: 0.4383% (STD: 0.6070, 0.5287)
	TCO2 (Level 1)	CV% and STD within acceptable limits for diagnostic assays.	Total CV%: 4.7153%; Run to Run CV%: 4.4432% (STD: 0.7824, 0.7373)
	TCO2 (Level 2)	CV% and STD within acceptable limits for diagnostic assays.	Total CV%: 5.2894%; Run to Run CV%: 4.7079% (STD: 1.8110, 1.6119)
Accuracy (Correlation)	Na+	Slope close to 1, Intercept close to 0, R close to 1 (indicating strong agreement with predicate).	Slope: 0.998, Intercept: 2.699, R: 0.982
	K+	Slope close to 1, Intercept close to 0, R close to 1 (indicating strong agreement with predicate).	Slope: 0.989, Intercept: 0.173, R: 0.991
	Cl-	Slope close to 1, Intercept close to 0, R close to 1 (indicating strong agreement with predicate).	Slope: 0.960, Intercept: 4.091, R: 0.966
	TCO2	Slope close to 1, Intercept close to 0, R close to 1 (indicating strong agreement with predicate).	Slope: 0.909, Intercept: 2.037, R: 0.975

Note: The implicit criteria are based on standard expectations for clinical chemistry assays and the goal of demonstrating equivalence to a predicate device. Specific numerical targets for acceptance are not provided in the document.

2. Sample Size and Data Provenance

Precision Study (Test Set):
- Sample Size: For each analyte (Na+, K+, Cl-, TCO2) at each of the two levels of serum controls, data from 45 total observations (N=45) were used. This was derived from 3 runs per day, 3 times per run for 5 days (3 x 3 x 5 = 45). For "Run to Run" precision, N=15 for each analyte at each level (presumably representing the 5 days of testing with 3 runs per day as a unit).
- Data Provenance: Not explicitly stated, but given the US manufacturer (ALKO Diagnostic Corporation, Holliston, MA) and the use of the Dade Dimension system, it's highly likely the data was collected in the United States. The study appears to be prospective for the purposes of this 510(k) submission, as it describes data collection for the specific purpose of demonstrating performance equivalence.
Accuracy (Correlation) Study (Test Set):
- Sample Size:
  - Na+, K+, Cl-: 156 patient serum samples and 12 control samples (Total N=168).
  - TCO2: 76 patient serum samples.
- Data Provenance: Not explicitly stated, but likely United States (similar reasoning as above). The mention of "patient serum samples" suggests the data was collected for this study, making it prospective in nature.

3. Number of Experts and Qualifications for Ground Truth

This submission describes calibration standards for an in vitro diagnostic chemistry system. The ground truth for such devices is typically established through:
- Reference Methods: Highly accurate and precise analytical methods used to assign true values to calibrator and control materials.
- Predicate Device Performance: The primary "ground truth" or reference for this 510(k) is the performance of the Dade MultiPLY™ Standard Reagents already cleared for use.
There is no mention of human experts (like radiologists) being used to establish ground truth for this type of IVD device. The "ground truth" is analytical and comparative to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. This type of IVD submission, involving calibration standards and analytical performance, does not typically involve adjudication by human experts in the way clinical diagnostic imaging studies might. The comparison is objective, based on analytical values generated by the instruments with different calibrators.

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

No, an MRMC comparative effectiveness study was not done. This type of study focuses on human reader performance (e.g., radiologists interpreting images) with and without AI assistance. This 510(k) pertains to chemical calibration standards and analytical device performance, not human interpretation.

6. Standalone (Algorithm Only) Performance

Essentially, yes, this is a standalone performance assessment in its context. The "device" in this case is the ALKO calibration standard. The studies assess the performance of the Dade Dimension instrument calibrated with ALKO standards (standalone performance of the calibrator-instrument system) against the same instrument calibrated with the predicate Dade standards. There is no human-in-the-loop component in the analytical measurements themselves.

7. Type of Ground Truth Used

The ground truth in the context of this submission is effectively the performance of the predicate device (Dade MultiPLY™ Standard Reagents).
- For the precision study, the ground truth is the inherent analytical variability of the system when calibrated with ALKO reagents (measured against itself).
- For the accuracy (correlation) study, the ground truth for comparison is the values obtained when the Dade Dimension system is calibrated with Dade's own standards. The goal is to show that using ALKO standards yields comparable results.

8. Sample Size for the Training Set

No separate training set is explicitly mentioned or relevant for this type of 510(k) submission. This device (calibration standard) is not an AI algorithm that "learns" from data. The studies performed are verification and validation studies (precision and accuracy) to demonstrate the product's performance against established benchmarks (the predicate device).

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

Not applicable. As there is no "training set" in the AI sense, there is no ground truth established for a training set. The relevant ground truth (predicate device performance) is referenced directly for the test/comparison studies.

Summary

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K970921

510(k) Summary

ALKO Standards A,B, and C for Dade Dimension® Chemistry Systems with MultiPLY™ Integrated Multisensor module Installed

APR -8 1997

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The A,B . C Standards are intended for use in calibrating Nat, K., Cl. and TCO, analytes on the Dade Dimension Chemistry Systems. Dade Chemistry Systems Inc. is the original equipment manufacturer (OEM) of the system and of predicate Standard Reagents which are necessary for the continued operation and use of the system.

The ALKO products stated are currently cleared under docket K.926518. Information herein will support ALKO's position to extend the intended use of these products to the Dade Dimension Chemistry System with MultiPLY™ Integrated Multisensor module installed. The MultiPLY™ Integrated Multisensor module measures Na K . Cl by using Integrated Multiple Technology means. The TCO2 analyte is measured by the system's Ion Selective Electrode. The ALKO Standard Reagents are intended to serve as direct replacements to like named products manufactured by Dade Chemistry Systems Inc.(formally Dupont International). ALKO Product A202-0 (Standard A) is equivalent to Dade Dimension Chemistry System product S540 (MultiPLY™ Standard A). ALKO product A103-0 (Standard B) is equivalent to Dade Dimension Chemistry System product S550 (MultiPLY™ Standard B). ALKO product A200-0 (Standard C ) is equivalent to Dade Dimension Chemistry System product S560 (MultiPLY™ Standard C). For marketing purposes ALKO will assign new product numbers for the extended use labeling.

ALKQ uses a similar composition, description and packaging design as that used by Dade Chemistry Systems Inc. in its products. ALKO has shown performance equivalence of its products to Dade Chemistry Systems products in the following manner:

Through a method comparison where results obtained on a Dade Dimension Chemistry O System with IMT installed, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Dade products; and
Through a precision study where ALKO products were installed on a Dade Dimension O Chemistry System with IMT installed and samples were measured over 20 runs.

A summary of the results of these studies follows:

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Page 2 / ALKO 510(k) Summary for Dade Dimension® System with IMT installed.

Precision Data

Precision data was collected from the analysis of two levels of serum controls measured three runs per day, three times per run for 5 days on a Dade Dimension System with IMT installed for Na*, K*, C I *, TCO2 calibrated with ALKO reagents.

Analyte		N	Mean	STD	CV%	Min	Max
Na+	Total	45	121.0	1.2285	1.0149	120	124
	Run to Run	15	121.0	0.7588	0.6269	120	122
K+	Total	45	2.70	0.0494	1.8308	2.6	2.8
	Run to Run	15	2.70	0.0333	1.2328	2.6	2.7
Cl-	Total	45	78.5	0.4999	0.6367	78	79
	Run to Run	15	78.5	0.3189	0.4062	78	79
TCO2	Total	45	16.59	0.7824	4.7153	14.6	18.0
	Run to Run	15	16.59	0.7373	4.4432	14.8	17.5

Level 1

Level 2

Analyte		N	Mean	STD	CV%	Min	Max
Na+	Total	45	180.0	1.0217	0.5677	178	183
	Run to Run	15	180.0	0.7350	0.4084	179	181
K+	Total	45	6.45	0.0542	0.8393	6.4	6.6
	Run to Run	15	6.45	0.0361	0.5595	6.4	6.5
Cl-	Total	45	120.6	0.6070	0.5032	119	122
	Run to Run	15	120.6	0.5287	0.4383	120	122
TCO2	Total	45	34.24	1.8110	5.2894	29.7	39.3
	Run to Run	15	34.24	1.6119	4.7079	31.0	37.1

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Accuracy by Correlation with Dade MultiPLY™ Standard Reagents

Correlation data was collected from 156 patient serum samples and 12 control samples for Na , K , Cl and from 76 patient serum sampes for TCQ2 , measured on a Dade Dimension System with IMT installed, calibrated with ALKO reagents as compared with Dade reagents separately. A Linear Regression Analysis was performed using the Dade data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation Y = a + bX.

Analyte	N	Slope	Intercept	R*	Range
Na+	168	0.998	2.699	0.982	120 - 180
K+ **	166	0.989	0.173	0.991	2.6 - 7.6
Cl-	168	0.960	4.091	0.966	78 - 122
TCO2	76	0.909	2.037	0.975	4.8 - 34.4

*R = Correlation Coefficient

** Two outliners excluded

I hope that you find this information useful and informative.

Janet G. McBath

Janet A.McGrath Regulatory Affairs

3/1/97

(date prepared)

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Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.