(65 days)
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No
The device is a chemical reagent for a standard enzymatic assay, and the description focuses on the chemical reaction and performance characteristics of the reagent itself, not on any computational analysis or interpretation of results using AI/ML.
No
The device is a reagent for in vitro diagnostic testing, used for the quantitation of creatine kinase. It does not directly provide therapy.
Yes
Explanation: The "Intended Use/Indications for Use" section explicitly states that the HiChem CK/NAC Reagent is "intended for the quantitation of creatine kinase in serum," and that "elevated serum creatine kinase are diseases of the heart and skeletal muscle." This indicates that the device measures a biological parameter to aid in the diagnosis of diseases.
No
The device is a chemical reagent intended for laboratory use, not a software-only medical device. It is a physical substance used in a chemical reaction to measure creatine kinase.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "quantitation of creatine kinase in serum and n homent of had not headly no room, seevated serum creatine kinase are diseases of the heart and skeletal muscle." This clearly indicates the device is used to analyze a biological sample (serum) to provide information about a patient's health status (related to heart and skeletal muscle diseases).
- Device Description: The description details how the reagent works to determine creatine kinase activity through enzymatic reactions and measurement of NADH. This is a typical process for in vitro diagnostic assays.
- Performance Studies: The document describes performance studies including linearity, precision, and comparisons to other reagents using serum and plasma specimens. These are standard evaluations for IVD devices to demonstrate their analytical performance.
- Reference Devices: The mention of "Reference Device(s)" like BMD CK/NAC Reagent and Sigma Diagnostics Creatine Kinase (CK) Reagent, which are also IVD products, further supports that the HiChem CK/NAC Reagent falls into the same category.
The core function of the device is to perform a test on a biological sample outside of the body to aid in the diagnosis or monitoring of a medical condition, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HiChem CK/NAC Reagent (product no. 70003) is intended for the quantitation of creatine kinase in serum and n homent of had not headly no room, seevated serum creatine kinase are diseases of the heart and skeletal muscle.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The HiChem CK/NAC Reagent determines creatine kinase by enzymation of adenosine diphosphate in the The rionoment of creatine the sphosphate. The rate of this reaction, and the activity of creatine kinase in the sociment is determined through the measurement of NADH which is formed through a series of linked enzymatic reactions.
The HiChern CK/NAC Reagent is intended to be used either as a manual procedure or on clinical analyzers which can THE HONEY ON WO Treagon IS The reagent is supplied as two liquit-stable components which are combined, ether adomails no roquined manyalance "The reason is to to series CK/NAC Reagent Buffer. The CK/NAC Bubstrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, The comparison of the mandal procedure to the Sigme Creatine Kinase (CK) Reagent and the validation of the chemical additives and reconstituted stability claims.
The recovery of creatine kinase using HiChem CK/NAC Reagent as a manual method at both 30°C and 37°C reaction temperatures is linear to at least 2000 U/L as shown by the recovery of linearity standards which span the claimed linear range. Regression statistics are shown below.
(Recoveries at 30°C) = 6.1 U/L + 0.9918 x (Standard Activity), r squared = 0.9998, s sub yx = 8.1 U/L
(Recoveries at 37°C) = 2.5 U/L + 0.9867 x (Standard Activity), r squared = 0.9998, s sub yx = 10.7 U/L
Precision, demonstrated by replicate assay of commercially available control sera, is shown below.
Serum control 1: n = 30, mean = 50 U/L, within-run SD = 1.5 U/L, total SD = 1.6 U/L
Serum control 2: n = 30, mean = 378 U/L, within-run SD = 5.3 U/L, total SD = 7.8 U/L
Serum control 3: n = 30, mean = 1048 U/L, within-run SD = 10.3 U/L, total SD = 18.6 U/L
Creatine kinase recoveries of 90 mixed serum and plasma specimens are compared between the HiChem and Sigma reagents. Least squares regression statistics are shown below.
(HiChem Results) == 0.6 U/L + 0.990 x (Sigma Results) S yx = 8.5 U/L. r squared = 0.991.
The use of heparin and EDTA are shown to be acceptable chemical additives by comparison of spiked and unspiked serum pools. In all cases, the biases observed were less than 2% and statistically insignificant at the 95% confidence level.
The stability of the combined working reagent over 2 weeks at 2-8°C and 1 day at 18-25°C are documented through the recovery of serum controls which range from 50 to 1200 U/L CK at 37 C. In all cases, the observed shifts in standard recovery were less than the greater of 4 U/L or 5%.
The effectiveness of the automated Hitachi 704 procedure is shown by the recovery of linearity standards, the precision of control recoveries, the recovery of serum controls over both the callbration stability claim, and the comparison of patient specimen recoveries to the BMD CK/ NAC Reagent.
The recovery of creatine kinase using HiChern CK/NAC Reagent as an automated method is linear to at least 2,400 U/L as shown by the recovery of eleven linearity standards which span the claimed linear range. Regression statistics are shown below.
Syx = 3.4 U/L. (HiChem Recoveries) = -0.2 U/L + 1.0013 x (Activity), r squared = 1.0000,
Precision, demonstrated by replicate assay of commercially available control sera, is shown below.
Serum control 1: n = 60, mean = 53 U/L, within-run SD = 0.9 U/L, total SD = 1.2 U/L
Serum control 2: n = 60, mean = 415 U/L, within-run SD = 1.4 U/L, total SD = 3.0 U/L
Serum control 3: n = 60, mean = 1183 U/L, within-run SD = 3.4 U/L, total SD = 6.9 U/L
Creatine kinase recoveries of 126 mixed serum and plasma speciment the HiChern and BMD reagents using least squares regression, yield the following statistics.
Sy.x = 3.05 U/L. (HiChem Results) = 0.0 U/L + 1.048 x (BMD Results) r = 0.9994.
The 24 hour calibration stability claim is documented through the recovery of serum controls which span from approximately 50 to 1,200 U/L CK. In all cases, the observed shifts in recoveries over 24 hours without calibration are less than the greater of 1 U/L or 0.25%. The on-board stability cleim is documented through the recovery of the same serum controls. The observed shifts in recoveries over the 21 day stability claim are no greater than 3.5%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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§ 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.
0
HiChem
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION
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.
AUG 1 5 1996
HiChem CK/NAC Reagent (product no. 70003) is intended for the quantitation of creatine kinase in serum and n homent of had not headly no room, seevated serum creatine kinase are diseases of the heart and skeletal muscle.
The HiChem CK/NAC Reagent determines creatine kinase by enzymation of adenosine diphosphate in the The rionoment of creatine the sphosphate. The rate of this reaction, and the activity of creatine kinase in the sociment is determined through the measurement of NADH which is formed through a series of linked enzymatic reactions.
The HiChern CK/NAC Reagent is intended to be used either as a manual procedure or on clinical analyzers which can THE HONEY ON WO Treagon IS The reagent is supplied as two liquit-stable components which are combined, ether adomails no roquined manyalance "The reason is to to series CK/NAC Reagent Buffer. The CK/NAC Bubstrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
The HiChem CK/NAC Reagent is substantially equivalent to the BMD CK/NAC Reagent, product no. 816360, manufactured by The hiloger Manhheim Corp., Indianapolis, IN., and the Sigma Diagnostics Creatine Kinase (CK) Reagent, procedure no. 47-Doomings maintinent ookin maanstics, St. Louis, MO. All three reagents support the same intended use and produce e vivalent results with the same clinical purpose. In addition, they are methodology which determines creatine kinse (CK ) through the measurement of NADH production. Finally, all reagents are sold in a generic format which evealine made (UT) infough the neadly one of supports its use on various instruments through procedure supplements (application sheets).
The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, The comparison of the mandal procedure to the Sigme Creatine Kinase (CK) Reagent and the validation of the chemical additives and reconstituted stability claims.
The recovery of creatine kinase using HiChem CK/NAC Reagent as a manual method at both 30°C and 37°C reaction temperatures is linear to at least 2000 U/L as shown by the recovery of linearity standards which span the claimed linear range. Regression statistics are shown below.
| (Recoveries at 30°C) = 6.1 U/L + 0.9918 x (Standard Activity), | $r^2$ = 0.9998, | $s_{yx}$ = 8.1 U/L |
|---|---|---|
| (Recoveries at 37°C) = 2.5 U/L + 0.9867 x (Standard Activity), | $r^2$ = 0.9998, | $s_{yx}$ = 10.7 U/L |
Precision, demonstrated by replicate assay of commercially available control sera, is shown below.
| Specimen | n | mean | within-run SD | total SD |
|---|---|---|---|---|
| Serum control 1 | 30 | 50 U/L | 1.5 U/L | 1.6 U/L |
| Serum control 2 | 30 | 378 U/L | 5.3 U/L | 7.8 U/L |
| Serum control 3 | 30 | 1048 U/L | 10.3 U/L | 18.6 U/L |
Creatine kinase recoveries of 90 mixed serum and plasma specimens are compared between the HiChem and Sigma reagents. Least squares regression statistics are shown below.
(HiChem Results) == 0.6 U/L + 0.990 x (Sigma Results) S yx = 8.5 U/L. r2 = 0.991.
The use of heparin and EDTA are shown to be acceptable chemical additives by comparison of spiked and unspiked serum pools. In all cases, the biases observed were less than 2% and statistically insignificant at the 95% confidence level.
The stability of the combined working reagent over 2 weeks at 2-8°C and 1 day at 18-25°C are documented through the recovery of serum controls which range from 50 to 1200 U/L CK at 37 C. In all cases, the observed shifts in standard recovery were less than the greater of 4 U/L or 5%.
The effectiveness of the automated Hitachi 704 procedure is shown by the recovery of linearity standards, the precision of control recoveries, the recovery of serum controls over both the callbration stability claim, and the comparison of patient specimen recoveries to the BMD CK/ NAC Reagent.
The recovery of creatine kinase using HiChern CK/NAC Reagent as an automated method is linear to at least 2,400 U/L as shown by the recovery of eleven linearity standards which span the claimed linear range. Regression statistics are shown below.
Syx = 3.4 U/L. (HiChem Recoveries) = -0.2 U/L + 1.0013 x (Activity), r2 = 1.0000,
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Precision, demonstrated by replicate assay of commercially available control sera, is shown below.
| Specimen | n | mean | within-run SD | total SD |
|---|---|---|---|---|
| Serum control 1 | 60 | 53 U/L | 0.9 U/L | 1.2 U/L |
| Serum control 2 | 60 | 415 U/L | 1.4 U/L | 3.0 U/L |
| Serum control 3 | 60 | 1183 U/L | 3.4 U/L | 6.9 U/L |
Creatine kinase recoveries of 126 mixed serum and plasma speciment the HiChern and BMD reagents using least squares regression, yield the following statistics.
Sy.x = 3.05 U/L. (HiChem Results) = 0.0 U/L + 1.048 x (BMD Results) r = 0.9994.
The 24 hour calibration stability claim is documented through the recovery of serum controls which span from approximately 50 to 1,200 U/L CK. In all cases, the observed shifts in recoveries over 24 hours without calibration are less than the greater of 1 U/L or 0.25%. The on-board stability cleim is documented through the recovery of the same serum controls. The observed shifts in recoveries over the 21 day stability claim are no greater than 3.5%.
The HiChem CK/NAC Reagent is shown to be safe and effective and substantially equivalent to the BMD CK/NAC Reagent, moduct no. 816360, manufactured by Boehringer Mannheim Corp., Indianapolis, IN., and the Sigma Diagnostics Creatine Kinase (CK) Reagent, procedure no. 47-UV manufactured by Sigma Diagnostics, St. Louis, MO.
Wynn Stoker
Manager of Regulatory A HiChem Diagnostics