Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The device description mentions a "quadratic fit through zero algorithm" for constructing the dose response curve, which is a standard statistical method, not AI/ML. There are no mentions of AI, DNN, or ML in the document.

Therapeutic

No
The device is described as an "in vitro diagnostic procedure" intended for the "quantitative determination of CK-MB." It aids in the "diagnosis of acute myocardial infarction" but does not provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic procedure is a solid-phase enzyme immunoassay intended for the quantitative determination of CK-MB in human serum or plasma... When used in combination with other clinical data... measurement of CK-MB aids in the diagnosis of acute myocardial infarction." This clearly indicates its purpose is to aid in diagnosis.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic procedure involving a solid-phase enzyme immunoassay with chemical reagents and magnetic particles, which are physical components, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The very first sentence of the "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic procedure is a solid- phase enzyme immunoassay intended for the quantitative determination of CK-MB in human serum or plasma on the Technicon Immuno 1 system."

This statement clearly identifies the device as an in vitro diagnostic procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This in vitro diagnostic procedure is a solid- phase enzyme immunoassay intended for the quantitative determination of CK-MB in human serum or plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of CK-MB aids in the diagnosis of acute myocardial infarction.

Product codes (comma separated list FDA assigned to the subject device)

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Device Description

The assay is an enzyme label sandwich assay using two monoclonal antibodies. A CK-MB specific antibody is labelled with fluorescein and the Fab' fragment of an antibody specific for the B subunit is labelled with alkaline phosphatase( ALP) The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein ( IMP reagent). Sample or calibrator. R1 reagent containing fluorescein - antibody conjugate, R2 reagent containing ALP-antibody conjugate and IMP reagent are mixed and incubated at 37°C. In the presence of CK-MB a fluorescein-conjugate: CK-MB: ALP-conjugate complex is formed and captured by the anti fluorescein antibodies on the magnetic particles. The particles are washed and pNPP (paranitrophenyl phosphate) substrate is added. The ALP in the antibody conjugate reacts with the pNPP to form para-nitrophenoxide and phosphate. Increasing absorbance due to the formation of paranitrophenoxide is monitored at 405 nm and 450 nm. The dose response curve is directly proportional to the concentration of CK-MB in the sample. A quadratic fit through zero is used to construct the dose response curve.

The assay has a range of 0 to 300 ng/ml and calibrators are provided with values of 0, 5, 10, 30, 100 and 300 ng/ml.

All the results reported herein were obtained by using a quadratic fit through zero algorithm to construct the standard curve.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

ASSAY PERFORMANCE: COMPARISON OF RESULTS WITH SERUM AND PLASMA SAMPLES

The comparison of Immuno 1 CK-MB results with serum and plasma samples was made with specimens submitted for CK-MB analysis from patients with suspected acute myocardial infarction. Only specimens from patients who had both serum and lithium heparin plasma samples drawn at the same time were used. Both serum and plasma samples from a patient were tested together. The study was conducted at three independent sites.

Table 1 COMPARISON OF IMMUNO 1 CK-MB RESULTS FOR SERUM AND PLASMA. Regression equation is Plasma CK-MB = Serum CK-MB(Slope) + Intercept
	Number of samples	Range of results (ng/mL)	Slope	Intercept ng/mL	r	Sy.x ng/mL
Site 1	45	0.34 to 24.75	1.06	0.23	0.984	1.30
Site 2	60	0.30 to 334.20	1.06	0.70	0.999	2.45
Site 3	55	0.64 to 202.36	1.06	0.56	0.995	4.69

PLASMA SAMPLE HANDLING

A total of 10 volunteers donated about 30 mL of blood each using heparinized vacutainer tubes. The plasma was separated and 10 mL was spiked with about 5 ng/mL of CK-MB. The plasma was then divided into 1mL aliquots. One was assayed immediately after preparation and the others were stored refrigerated or froxen at -20°C. At the intervals indicated in Table 3 an aliquot was tested on the Immuno 1. The results indicate that a sample can be stored refrigerated for at least 7 days without change in the Immuno 1 result or for one month frozen at -20°C. The results for the first 8 days were obtained using a calibration curve stored at the start of the study. The system was recalibrated for the results with frozen samples after one month storage. The results for the samples are the means of three replicates.

IMPRECISION: COMPARISON OF RESULTS WITH SERUM AND PLASMA SAMPLES

Results obtained in the first 8 days of the sample handling study described above were used to calculate the imprecision with plasma samples. This is shown in Table 3. Serum controls had been measured in each run and are included for comparison. There is no significant difference between the imprecision obtained for serum or plasma.

Table 3 : IMPRECISION WITH PLASMA SAMPLES
Sample	Mean (ng/mL)	Within-run SD (ng/mL)	Within-run CV (%)	Total SD (ng/mL)	Total CV (%)
Plasma 1	5.61	0.14	2.6	0.18	3.2
Plasma 2	6.65	0.14	2.1	0.18	2.8
Plasma 3	5.28	0.15	2.9	0.14	2.6
Plasma 4	4.48	0.09	2.1	0.11	2.4
Plasma 5	6.14	0.12	1.9	0.13	2.1
Plasma 6	6.03	0.08	1.4	0.10	1.7
Plasma 7	5.23	0.12	2.3	0.12	2.3
Plasma 8	4.27	0.09	2.1	0.10	2.3
Plasma 9	4.51	0.10	2.3	0.11	2.4
Plasma 10	7.27	0.17	2.3	0.54	7.4
Serum Control 1	3.31	0.11	3.3	0.12	3.7
Serum Control 2	12.75	0.15	1.2	0.28	1.2

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.

Summary

0

Attachment 3

K96 1412

SUMMARY OF SAFETY AND EFFECTIVENESS

CK-MB METHOD FOR THE IMMUNO 1 SYSTEM

Listed below are a comparison of the performance between serum and plasma samples on the Immuno 1 CK-MB method ( T01-3587-51). The information used in this summary of Safety and Effectiveness was extracted from the CK-MB method sheet ( attachment ) and file at Bayer Corp.

The reagents, calibrators and software are the same regardless of whether serum or plasma is used as the sample.

INTENDED USE

This in vitro diagnostic procedure is a solid- phase enzyme immunoassay intended for the quantitative determination of CK-MB in human serum or plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of CK-MB aids in the diagnosis of acute myocardial infarction.

ASSAY DESCRIPTION

The assay is an enzyme label sandwich assay using two monoclonal antibodies. A CK-MB specific antibody is labelled with fluorescein and the Fab' fragment of an antibody specific for the B subunit is labelled with alkaline phosphatase( ALP) The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein ( IMP reagent). Sample or calibrator. R1 reagent containing fluorescein - antibody conjugate, R2 reagent containing ALP-antibody conjugate and IMP reagent are mixed and incubated at 37°C. In the presence of CK-MB a fluorescein-conjugate: CK-MB: ALP-conjugate complex is formed and captured by the anti fluorescein antibodies on the magnetic particles. The particles are washed and pNPP (paranitrophenyl phosphate) substrate is added. The ALP in the antibody conjugate reacts with the pNPP to form para-nitrophenoxide and phosphate. Increasing absorbance due to the formation of paranitrophenoxide is monitored at 405 nm and 450 nm. The dose response curve is directly proportional to the concentration of CK-MB in the sample. A quadratic fit through zero is used to construct the dose response curve.

The assay has a range of 0 to 300 ng/ml and calibrators are provided with values of 0, 5, 10, 30, 100 and 300 ng/ml.

All the results reported herein were obtained by using a quadratic fit through zero algorithm to construct the standard curve.

1

ASSAY PERFORMANCE: COMPARISON OF RESULTS WITH SERUM AND PLASMA SAMPLES

The comparison of Immuno 1 CK-MB results with serum and plasma samples was made with specimens submitted for CK-MB analysis from patients with suspected acute myocardial infarction. Only specimens from patients who had both serum and lithium heparin plasma samples drawn at the same time were used. Both serum and plasma samples from a patient were tested together. The study was conducted at three independent sites. The results of the regression analysis is shown in Table 1 below.

| Table 1
COMPARISON OF IMMUNO 1 CK-MB RESULTS FOR SERUM AND PLASMA.
Regression equation is

Plasma CK-MB = Serum CK-MB(Slope) + Intercept
	Number
of samples	Range of results
(ng/mL)	Slope	Intercept
ng/mL	r	Sy.x
ng/mL
Site 1	45	0.34 to 24.75	1.06	0.23	0.984	1.30
Site 2	60	0.30 to 334.20	1.06	0.70	0.999	2.45
Site 3	55	0.64 to 202.36	1.06	0.56	0.995	4.69

2

PLASMA SAMPLE HANDLING

A total of 10 volunteers donated about 30 mL of blood each using heparinized vacutainer tubes. The plasma was separated and 10 mL was spiked with about 5 ng/mL of CK-MB. The plasma was then divided into 1mL aliquots. One was assayed immediately after preparation and the others were stored refrigerated or froxen at -20°C. At the intervals indicated in Table 3 below an aliquot was tested on the Immuno 1. The results indicate that a sample can be stored refrigerated for at least 7 days without change in the Immuno 1 result or for one month frozen at -20°C. The results for the first 8 days were obtained using a calibration curve stored at the start of the study. The system was recalibrated for the results with frozen samples after one month storage. The results for the samples are the means of three replicates

| Table 2
IMMUNO 1 CK-MB RESULTS FOR PLASMA SAMPLES STORED UNDER DIFFERENT

CONDITIONS.
	Room
temperature	Refrigerated at 2 - 8°C					Frozen at
-20°C
Sample	Immediate	8 hours	24 hours	48 hours	7 days	8 days	1 month
1	5.6	5.8	5.5	5.5	5.8	5.4	5.6
2	6.7	7.0	6.7	6.5	6.6	6.6	6.3
3	5.2	5.3	5.3	5.3	5.2	5.3	5.2
4	4.4	4.6	4.5	4.5	4.3	4.5	4.2
5	6.1	6.4	6.2	6.1	6.1	6.0	5.8
6	5.9	6.2	6.1	6.0	6.0	6.0	5.7
7	5.1	5.4	5.2	5.3	5.2	5.2	4.8
8	4.2	4.5	4.3	4.3	4.2	4.3	3.9
9	4.4	4.6	4.5	4.6	4.5	4.5	4.3
10	6.8	6.9	7.4	8.2	7.4	7.0	7.3

28

3

IMPRECISION: COMPARISON OF RESULTS WITH SERUM AND PLASMA SAMPLES

Results obtained in the first 8 days of the sample handling study described above were used to calculate the imprecision with plasma samples. This is shown in Table 3. Serum controls had been measured in each run and are included for comparison. There is no significant difference between the imprecision obtained for serum or plasma.

Table 3 : IMPRECISION WITH PLASMA SAMPLES
Sample	Mean
(ng/mL)	Within-run
SD (ng/mL)	Within-run
CV (%)	Total SD
(ng/mL)	Total CV
(%)
Plasma 1	5.61	0.14	2.6	0.18	3.2
Plasma 2	6.65	0.14	2.1	0.18	2.8
Plasma 3	5.28	0.15	2.9	0.14	2.6
Plasma 4	4.48	0.09	2.1	0.11	2.4
Plasma 5	6.14	0.12	1.9	0.13	2.1
Plasma 6	6.03	0.08	1.4	0.10	1.7
Plasma 7	5.23	0.12	2.3	0.12	2.3
Plasma 8	4.27	0.09	2.1	0.10	2.3
Plasma 9	4.51	0.10	2.3	0.11	2.4
Plasma 10	7.27	0.17	2.3	0.54	7.4
Serum Control 1	3.31	0.11	3.3	0.12	3.7
Serum Control 2	12.75	0.15	1.2	0.28	1.2

4

SAMPLE HANDLING INSTRUCTIONS

Serum and plasma (heparin) samples may be used. Samples may be stored for one week at 2 to 8°C or for one month at -20°C. Frozen samples should be thawed at room temperature and mixed thoroughly before use. Thawed samples should not be refrozen. For optimal results the sample must be free of particulate matter.

Increased clotting times may occur with samples from patients receiving anticoagulant or thrombolytic therapy. In those cases only plasma samples should be used! Serum samples containing anticoagulants or thrombolytic agents may vield false positive results on a random basis. Plasma samples collected from these patients using lithium heparin do not appear to exhibit similar problems.

Ensure that clot formation is complete before centrifugation of serum samples. Fibrin may appear in stored plasma samples. All plasma samples should be centrifuged or filtered before analysis to ensure removal of particulate matter.

5

Image /page/5/Figure/0 description: The image shows a product label specification for in vitro diagnostics. The label includes the product name "Technicon Immuno 10 CK-MB" and specifies that it contains reagents. The label also includes information such as the product code "T01-3587-51", the net contents "1 x 13.6 mL" and "1 x 6.6 mL", and the discrete number. The label also contains the word "DRAFT" and a signature with the date 11/18/94.

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Attachment 4