(77 days)
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No
The document describes a control product for in vitro diagnostic tests and does not mention any AI or ML components in its description or performance studies.
No
This device is for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry and clinical chemistry systems, not for direct therapeutic treatment.
No
This device is described as a "control product" intended to assess the analytical performance of immunochemistry and clinical chemistry systems. It is used to evaluate system performance and aid in troubleshooting, not to directly diagnose a patient's condition.
No
The device description clearly states it is a "human serum matrix containing creatine kinase isoenzymes, lactate dehydrogenase isoenzymes 1 and 2, and myoglobin," which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "This product is intended for in vitro diagnostic use as a control product...".
- Device Description: The description details a product used to assess the performance of immunochemistry and clinical chemistry systems, which are used for in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device to predicate devices that are also described as controls for immunoassay and chemistry systems, further indicating its role in the IVD workflow.
N/A
Intended Use / Indications for Use
This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
DOCUMENT® CARDIAC Assayed Controls consist of three levels of a human serum matrix containing creatine kinase isoenzymes, lactate dehydrogenase isoenzymes 1 and 2, and myoglobin. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of total creatine kinase activity (CK), creatine kinase MB mass (CKMB), creatine kinase immunoinhibition (CKII), creatine kinase electrophoresis (CKELEC), total lactate dehydrogenase activity (LD), lactate de dehydrogenase electrophoresis for isoenzyme 1 and 2 (LD1; LD2), and myoqlobin (MYO).
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 equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the DOCUMENT®CARDIAC Assayed Control to that of Dade CK-MB/Myoglobin Immunoassay Controls, Abbott CK-MB Stat Controls, Bio-Rad Unassayed Chemistry Control, Beckman I.D-Zone Liquid CK Isoenzyme Control and Beckman I.D-Zone Normal LD Isoenzyme Liquid Control. The results show that the DOCUMENT®CARDIAC Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes.
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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
JUL 22 1996
Exhibit 21. 510(k) Summary
FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY DOCUMENI® CARDIAC Assayed Control, Levels I, III, III
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- Submitted by: CASCO Standards P.O. Box 970 Yarmouth, ME 04096
- Attention: Christine V. Beach Manager, Regulatory Affairs
(207) 878-7550 (207) 878-7578 FAX
May 5, 1996
- Product Name:
Proprietary Name: DOCUMENT® CARDIAC Assayed Control
Classification Name: Control, multiple analyte, assayed.
1
3. Predicate Device:
| Product: | Dade CK-MB/Myoglobin Immunoassay Control Level 1,2 and 3 |
|---|---|
| Catalog: | Level 1 (B5200-1), Level 2 (B5200-2), Level 3 (B5200-3) |
| Manufacturer: | Baxter Diagnostics, Inc., Deerfield, IL 60015-4633 |
| Analytes: | CK-MB, Myoglobin |
| Product: | Abbott IMx STAT CK-MB Controls, L, M, H |
| Catalog: | 7A28-10 |
| Manufacturer: | Abbott Laboratories, Abbott Park, IL 60064 |
| Analytes: | CK-MB |
| Product: | Bio-Rad Unassayed Chemistry Control (Human) Levels 1 and 2 |
| Catalog: | 16030 |
| Manufacturer: | Bio-Rad, ECS Division, Anaheim, CA 28506 |
| Analytes: | CK, LD |
| Product: | Beckman I.D-Zone Liquid CK Isoenzyme Control |
| Catalog: | 667990 |
| Manufacturer: | Beckman Instruments, Brea, CA |
| Analytes: | CK |
| Product: | Beckman I.D-Zone Normal LD Isoenzyme Liquid Control |
| Catalog: | 439090 |
| Manufacturer: | Beckman Instruments, Brea, CA |
| Analytes: | LD |
- DOCUMENT® CARDIAC Assayed Controls consist of three 4. Product Description: levels of a human serum matrix containing creatine kinase isoenzymes, lactate dehydrogenase isoenzymes 1 and 2, and myoglobin. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of total creatine kinase activity (CK), creatine kinase MB mass (CKMB), creatine kinase immunoinhibition (CKII), creatine kinase electrophoresis (CKELEC), total lactate dehydrogenase activity (LD), lactate de dehydrogenase electrophoresis for isoenzyme 1 and 2 (LD1; LD2), and myoqlobin (MYO).
-
- Intended Use: This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
2
6. Comparison to the Predicate Device:
r
| Characteristic | DOCUMENT
CARDIAC Assayed
Control | Dade
CK-MB/Myoglobin
Immunoassay
Control | Abbott CK-MB
Stat Control | Bio-Rad Liquichek
Unassayed
Chemistry Control |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Assayed control for
monitoring accuracy
and precision of total
CK and LD activity,
CKMB
immunoassay, CK
Immunoinhibition, CK
isoenzyme
electrophoresis, LD1
and LD2 isoenzyme
electrophoresis,
myoglobin | Assayed control for
monitoring of the
accuracy and
precision of CK-MB
and myoglobin
analysis | None indicated | Unassayed control
for the monitoring of
the accuracy and
precision of
automated and
manual testing
procedures |
| Number of Levels | Three (3):
Level I, Level II,
Level III | Three (3):
Level 1, Level 2,
Level 3 | Three (3):
Low, Mid, High | Two (2):
Level 1, Level 2 |
| Type | Assayed | Assayed | Assayed | Unassayed |
| Analytes | 3 | 2 | 1 | Many |
| Volume | 2 mL | 3 mL | 8 mL | 5 mL |
| Matrix | Human serum, Liquid | Human source,
Lyophilized | Bovine serum,
Lyophilized | Human serum,
Liquid |
| Dilution | None required | None required | None required | None required |
| Unopened Stability | Until Expiration Date | Until Expiration
Date | Until Expiration
Date | Until Expiration
Date |
| Open Stability | 45 Days | CKMB: 20 Days
MYO: 14 Days | None indicated | 15 Days |
| Container | Plastic,
Dropper Tip | Glass | Plastic,
Dropper Tip | Glass |
3
| 6. | Comparison to the Predicate Device (Continued): |
|---|---|
| ---- | ------------------------------------------------- |
| Characteristic | DOCUMENT®
CARDIAC Assayed Control | Beckman I.D-Zone
Liquid CK Isoenzyme Control | Beckman I.D-Zone
Liquid LD Isoenzyme Control |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Intended Use | Assayed control for monitoring accuracy and precision of total CK and LD activity, CKMB immunoassay, CK Immunoinhibition, CK isoenzyme electrophoresis, LD1 and LD2 isoenzyme electrophoresis, myoglobin | Assayed control for monitoring the overall reliability of CK isoenzyme procedures | Assayed control for monitoring the overall reliability of LD isoenzyme electrophoretic procedures |
| Number of Levels | Three (3):
Level I, Level II Level III | One (1) | One (1) |
| Type | Assayed | Assayed | Assayed |
| Analytes | 3 | 1 | 1 |
| Volume | 2 mL | 2 mL | 2 mL |
| Matrix | Human serum, Liquid | Human serum albumin, Liquid | Human serum, Liquid |
| Dilution | None required | None required | None required |
| Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date |
| Open Stability | 45 Days | 20 Days | 20 Days |
| Container | Plastic, Dropper Tip | Plastic, Dropper Tip | Plastic, Dropper Tip |
4
-
- Test Results: The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the DOCUMENT®CARDIAC Assayed Control to that of Dade CK-MB/Myoglobin Immunoassay Controls, Abbott CK-MB Stat Controls, Bio-Rad Unassayed Chemistry Control, Beckman I.D-Zone Liquid CK Isoenzyme Control and Beckman I.D-Zone Normal LD Isoenzyme Liquid Control. The results show that the DOCUMENT®CARDIAC Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes.