(27 days)
K.926518
Not Found
No
The document describes in vitro diagnostic solutions for calibrating chemistry systems and focuses on demonstrating equivalence to a predicate device through standard performance studies (method comparison, precision, correlation). There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic solution intended for calibrating chemistry systems, not for treating or diagnosing patients.
No.
The device is described as "In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation" and "intended for use in calibrating Nat, K., Cl. and TCO, analytes on the Dade Dimension Chemistry Systems." It is a calibrator, not a diagnostic device itself.
No
The device description explicitly states the products are "In Vitro Diagnostic Solutions" and "Standard Reagents," which are physical substances used for calibration, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states the standards are "intended for use in calibrating Nat, K., Cl. and TCO, analytes on the Dade Dimension Chemistry Systems." This describes a use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Device Description: The "Device Description" clearly states the products are "Class II (75JIX) In Vitro Diagnostic Solutions". This is a direct classification as an IVD.
- Performance Studies: The performance studies described involve testing the device's performance in a laboratory setting using patient samples and control samples, which is characteristic of IVD testing.
The information provided strongly indicates that this device is an IVD.
N/A
Intended Use / Indications for Use
The A,B . C Standards are intended for use in calibrating Nat, K., Cl. and TCO, analytes on the Dade Dimension Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
75JIX
Device Description
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 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Level 1:
- Na+: N=45, Mean=121.0, STD=1.2285, CV%=1.0149 (Total); N=15, Mean=121.0, STD=0.7588, CV%=0.6269 (Run to Run)
- K+: N=45, Mean=2.70, STD=0.0494, CV%=1.8308 (Total); N=15, Mean=2.70, STD=0.0333, CV%=1.2328 (Run to Run)
- Cl-: N=45, Mean=78.5, STD=0.4999, CV%=0.6367 (Total); N=15, Mean=78.5, STD=0.3189, CV%=0.4062 (Run to Run)
- TCO2: N=45, Mean=16.59, STD=0.7824, CV%=4.7153 (Total); N=15, Mean=16.59, STD=0.7373, CV%=4.4432 (Run to Run)
- Level 2:
- Na+: N=45, Mean=180.0, STD=1.0217, CV%=0.5677 (Total); N=15, Mean=180.0, STD=0.7350, CV%=0.4084 (Run to Run)
- K+: N=45, Mean=6.45, STD=0.0542, CV%=0.8393 (Total); N=15, Mean=6.45, STD=0.0361, CV%=0.5595 (Run to Run)
- Cl-: N=45, Mean=120.6, STD=0.6070, CV%=0.5032 (Total); N=15, Mean=120.6, STD=0.5287, CV%=0.4383 (Run to Run)
- TCO2: N=45, Mean=34.24, STD=1.8110, CV%=5.2894 (Total); N=15, Mean=34.24, STD=1.6119, CV%=4.7079 (Run to Run)
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.
- Na+: N=168, Slope=0.998, Intercept=2.699, R=0.982, Range=120 - 180
- K+: N=166, Slope=0.989, Intercept=0.173, R=0.991, Range=2.6 - 7.6 (two outliers excluded)
- Cl-: N=168, Slope=0.960, Intercept=4.091, R=0.966, Range=78 - 122
- TCO2: N=76, Slope=0.909, Intercept=2.037, R=0.975, Range=4.8 - 34.4
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.
K.926518
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.
Not Found
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
§ 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
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:
SHEET 11 OF 49
A Worldwide Supplier of Blood Gas and ISE
1
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 |
A Worldwide Supplier of Blood Gas and ISE
2
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)
SHEET 13 OF 42
A Worldwide Supplier of Blood Gas and ISE