(60 days)
Not Found
Paramax®, CLiNaK™
No
The device description and performance studies focus on chemical reagents for calibrating and diluting samples for an existing analyzer, with no mention of AI or ML.
No.
The device is described as In Vitro Diagnostic Solutions (calibrators and reagents) for calibrating electrodes and diluting samples for analyzers, which are used for diagnostic purposes, not for direct therapy.
No
The device is described as "Class II (75JIX) In Vitro Diagnostic Solutions" intended for calibrating and diluting samples for Paramax® CLiNaK™ Analyzers, which are the diagnostic devices. This device supports the diagnostic analyzer but does not perform diagnosis itself.
No
The device description clearly states the products are "In Vitro Diagnostic Solutions" and "Liquid Reagent," indicating they are physical substances (liquids) used for calibration and dilution, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are for "calibrating the electrodes of Paramax® CLiNaK™ Analyzers" and the ISE Liquid Reagent is used to "dilute samples measured on the Paramax® CLiNaK™ Analyzers." These analyzers are used to measure analytes in biological samples (implied by the mention of serum samples in the performance studies), which is a core function of in vitro diagnostics.
- Device Description: The description clearly states that the products are "Class II (75JIX) In Vitro Diagnostic Solutions." This directly identifies the device as an IVD.
- Performance Studies: The performance studies involve analyzing "pooled serum samples" and "controls" to assess the accuracy and precision of the device in the context of measuring analytes (Na+, K+, Cl-, and Li+). This type of testing on biological samples is characteristic of IVDs.
- Predicate Devices: The predicate devices are also described as "ISE Calibrant A," "ISE Calibrant B," and "ISE Liquid Reagent," which are components used in in vitro diagnostic testing.
All of these points strongly indicate that the device is intended for use in the in vitro examination of specimens derived from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The calibrators are intended for use in calibrating the electrodes of Paramax® CLiNaK™ Analyzers. The ISE Liquid Reagent is used to dilute samples measured on the Paramax® CLiNaK™ Analyzers. The ALKO calibrators and ISE Liquid Reagent are intended to serve as direct replacements to like named products manufactured by Baxter Diagnostics. Inc. (currently Dade International).
Product codes
75JIX
Device Description
The products encompassed by this 510(k) submission are Class II In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation. ALKO uses a similar composition, description and packaging design as that used by Baxter Diagnostics in its products.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Accuracy by Correlation with Baxter (Dade) ISE Reagents: Correlation data was collected from 60 pooled serum samples with Na+, K+, Cl- and Li+ values adjusted using NaCl, KCL and LiCl salts. The correlation study was performed on a Baxter CLiNaK™ ISE module, calibrated with ALKO and Baxter reagents separately. A Linear Regression Analysis was performed using OEM data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation Y = a + bX. One outlier for K+ and one outlier for Cl- data were expluded from the comparison. Outliers were excluded using a formula where if the individual value of the difference between the two methods is greater than four times the average absolute difference of all measurements then the individual is excluded.
- Precision Data: Na+, K+, Cl- and Li+ electrolyte precision data was collected from the analysis of controls measured on a Baxter CLiNaK™ ISE module (calibrated with all ALKO reagents) 3 times per run for a total of 20 runs. A separate calibration was performed prior to each run.
Key Metrics
Accuracy by Correlation with Baxter (Dade) ISE Reagents:
- Na+: N=60, Slope=1.002, Intercept=-0.174, R Sq=0.993, Range=63-203
- K+: N=58, Slope=1.002, Intercept=0.007, R Sq=0.998, Range=0.9-14.3
- Cl-: N=59, Slope=0.969, Intercept=2.798, R Sq=0.996, Range=41-170
- Li+: N=57, Slope=0.999, Intercept=0.022, R Sq=0.998, Range=0.0-5.93
Precision Data:
Na+:
- Level 1: Total N=60, Mean=146.2, STD=1.077, CV%=0.74, Min=144, Max=149; Run to Run N=20, Mean=146.2, STD=0.957, CV%=0.65, Min=144.7, Max=148.0
- Level 2: Total N=60, Mean=126.3, STD=1.118, CV%=0.89, Min=124, Max=129; Run to Run N=20, Mean=126.3, STD=0.719, CV%=0.57, Min=125.3, Max=127.7
K+: - Level 1: Total N=60, Mean=6.98, STD=0.102, CV%=1.46, Min=6.8, Max=7.3; Run to Run N=20, Mean=6.98, STD=0.085, CV%=1.22, Min=6.83, Max=7.17
- Level 2: Total N=60, Mean=3.95, STD=0.090, CV%=2.28, Min=3.7, Max=4.2; Run to Run N=20, Mean=3.95, STD=0.065, CV%=1.63, Min=3.83, Max=4.10
Cl-: - Level 1: Total N=60, Mean=107.0, STD=1.080, CV%=1.01, Min=105, Max=109; Run to Run N=20, Mean=107.0, STD=0.906, CV%=0.85, Min=105.3, Max=108.7
- Level 2: Total N=60, Mean=86.8, STD=1.501, CV%=1.73, Min=83, Max=90; Run to Run N=20, Mean=86.8, STD=1.337, CV%=1.54, Min=84.3, Max=89.3
Li+: - Level 1: Total N=60, Mean=0.446, STD=0.021, CV%=4.66, Min=0.40, Max=0.50; Run to Run N=20, Mean=0.446, STD=0.016, CV%=3.63, Min=0.423, Max=0.487
- Level 2: Total N=60, Mean=1.726, STD=0.0355, CV%=2.06, Min=1.65, Max=1.81; Run to Run N=20, Mean=1.726, STD=0.0244, CV%=1.41, Min=1.680, Max=1.790
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR 1 1 1996
Kracots
510(k) Summarv ALKO Calibrators and ISE Liquid Reagent for Baxter Diagnostics Paramax® CLiNaK™ Analyzers
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 calibrators are intended for use in calibrating the electrodes of Paramax® CLiNaK™ Analyzers. The ISE Liquid Reagent is used to dilute samples measured on the Paramax® CLiNaK™ Analyzers. Baxter Diagnostics, Inc. is the original equipment manufacturer (OEM) of the analyzer and of predicate Calibrators and ISE Liquid Reagent which are necessary for the continued operation and use of the analyzer.
The ALKO calibrators and ISE Liquid Reagent are intended to serve as direct replacements to like named products manufactured by Baxter Diagnostics. Inc. (currently Dade International). ALKO Product A611-151 (ALKO Calibrant A) is equivalent to Baxter Diagnostics Product B6110-151 (ISE Calibrant A). ALKO Product A611-152 (ALKO Calibrant B) is equivalent to Baxter Diagnostics Product B6110-152 (ISE Calibrant B). ALKO Product A611-153 (ALKO ISE Liquid Reagent) is equivalent to Baxter Diagnostics Product B6110-153 (ISE Liquid Reagent).
ALKO uses a similar composition, description and packaging design as that used by Baxter Diagnostics in its products. ALKO has shown performance equivalence of its products to Baxter products in the following manner:
- O Through a method comparison where results obtained on a Paramax® CLiNaK™ Analyzer calibrated with ALKO products were compared with results obtained on the same analyzer calibrated with Baxter products: and
- Through a precision study where ALKO products were installed on a Paramax® CLiNaK™ 0 Analyzer and samples were measured over 20 runs.
A summary of the results of these studies follows:
SHEET 3 OF 76
1
Accuracy by Correlation with Baxter (Dade) ISE Reagents
Correlation data was collected from 60 pooled serum samples with Na+, K+, Cl- and Li+ values adjusted using NaCl, KCL and LiCl salts. The correlation study was performed on a Baxter CLiNaK™ ISE module, calibrated with ALKO and Baxter reagents separately. A Linear Regression Analysis was performed using OEM data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation Y = a + bX. One outlier for K+ and one outlier for Cl- data were expluded from the comparison. Outliers were excluded using a formula where if the individual value of the difference between the two methods is greater than four times the average absolute difference of all measurements then the individual is excluded.
| Analyte | N | Slope | Intercept | R Sq | Range |
|---|---|---|---|---|---|
| Na+ | 60 | 1.002 | -0.174 | 0.993 | 63 - 203 |
| K+ | 58 | 1.002 | 0.007 | 0.998 | 0.9 - 14.3 |
| Cl- | 59 | 0.969 | 2.798 | 0.996 | 41 - 170 |
| Li+ | 57 | 0.999 | 0.022 | 0.998 | 0.0 - 5.93 |
R Sq = Correlation Coefficient Squared
Precision Data
Na+, K+, Cl- and Li+ electrolyte precision data was collected from the analysis of controls measured on a Baxter CLiNaK™ ISE module (calibrated with all ALKO reagents) 3 times per run for a total of 20 runs. A separate calibration was performed prior to each run.
| Level | N | Mean | STD | CV% | Min | Max | |
|---|---|---|---|---|---|---|---|
| 1 | Total | 60 | 146.2 | 1.077 | 0.74 | 144 | 149 |
| Run to Run | 20 | 146.2 | 0.957 | 0.65 | 144.7 | 148.0 | |
| 2 | Total | 60 | 126.3 | 1.118 | 0.89 | 124 | 129 |
| Run to Run | 20 | 126.3 | 0.719 | 0.57 | 125.3 | 127.7 |
Na+
2
Page 3 / ALKO 510(k) Summary for Paramax® CLiNaK™ Analyzer
| Level | N | Mean | STD | CV% | Min | Max | |
|---|---|---|---|---|---|---|---|
| 1 | Total | 60 | 6.98 | 0.102 | 1.46 | 6.8 | 7.3 |
| Run to Run | 20 | 6.98 | 0.085 | 1.22 | 6.83 | 7.17 | |
| 2 | Total | 60 | 3.95 | 0.090 | 2.28 | 3.7 | 4.2 |
| Run to Run | 20 | 3.95 | 0.065 | 1.63 | 3.83 | 4.10 |
CI-
| Level | N | Mean | STD | CV% | Min | Max | |
|---|---|---|---|---|---|---|---|
| 1 | Total | 60 | 107.0 | 1.080 | 1.01 | 105 | 109 |
| Run to Run | 20 | 107.0 | 0.906 | 0.85 | 105.3 | 108.7 | |
| 2 | Total | 60 | 86.8 | 1.501 | 1.73 | 83 | 90 |
| Run to Run | 20 | 86.8 | 1.337 | 1.54 | 84.3 | 89.3 |
Lit
| Level | N | Mean | STD | CV% | Min | Max | |
|---|---|---|---|---|---|---|---|
| 1 | Total | 60 | 0.446 | 0.021 | 4.66 | 0.40 | 0.50 |
| Run to Run | 20 | 0.446 | 0.016 | 3.63 | 0.423 | 0.487 | |
| 2 | Total | 60 | 1.726 | 0.0355 | 2.06 | 1.65 | 1.81 |
| Run to Run | 20 | 1.726 | 0.0244 | 1.41 | 1.680 | 1.790 |
I hope that you find this information useful and informative.
Brian L. Yacktman
Brian J. Young Director, Design and Regulatory Affairs
1/4/96
(date prepared)
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