(66 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.
No
The device is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry and clinical chemistry systems, not for treating diseases or conditions.
No
This device is described as a "control product" and "control material" intended to "assess the analytical performance of immunochemistry systems and clinical chemistry systems." It is used to ensure the accuracy and reliability of diagnostic systems, rather than directly diagnosing a patient's condition.
No
The device description clearly states it consists of a "human serum matrix containing 25 commonly monitored analytes," 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 that the 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 systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes." These systems are used to perform diagnostic tests on biological samples (human serum in this case).
- Function: The product serves as a "control material" to evaluate the "analytical performance" of these diagnostic systems. This is a key function of IVD control materials.
Therefore, based on the provided information, the device clearly falls under the definition of an In Vitro Diagnostic.
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
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Device Description
DOCUMENT® TDM ULTRA Assayed Controls consist of three levels of a human serum matrix containing 25 commonly monitored analytes. 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 blood acetaminophen (ACET), amikacin (AMI), carbamazepine (CARB), digoxin (DIG), disopyramide (DISO), ethanol (ETOH), ethosuximide (ETHO), gentamicin (GENT)e lidocaine (LIDO), methotrexate (METH), N-acetylprocainamide (NAPA), phenobarbital (PHENO), phenytoin (PHENY), primidone (PRIM), procainamide (PROC), quinidine (QUIN), salicylate (SAL), theophylline (THEO), thyroid-stimulating hormone (hTSH), thyroxine (T4), tobramycin (TOB), triiodothyronine (T3), T-Uptake (TU), valproic acid (VAL), and vancomycin (VANCO).
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
The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the DOCUMENT TDM ULTRA Assayed Control to that of Dade Immunoassay Controls Comprehensive Tri-Level, Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls and Abbott REA Ethanol Serum Control. The results show that the DOCUMENT*TDM ULTRA 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
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Predicate Device(s)
K960544, Dade Immunoassay Controls Comprehensive Tri-Level, Levels 1, 2, and 3, Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls, Low and High Levels, Abbott REA Ethanol Serum Control, Levels L, M, and H
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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
K960544 MAR 22
Exhibit 15. 510(k) Summary
FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY DOCUMENT® TDM ULTRA Assayed Control, Levels I, III, III
-
- Submitted by: CASCO Standards P.O. Box 970 Yarmouth, ME 04096
- Christine V. Beach Attention: Manager, Regulatory Affairs
(207) 878-7550 (207) 878-7578 FAX
January 5, 1996
- Product Name:
Proprietary Name: DOCUMENT® TDM ULTRA Assayed Control
Classification Name: Control, multiple analyte, assayed.
1
3. Predicate Device:
| Product: | Dade Immunoassay Controls Comprehensive Tri-Level, Levels 1, 2, and 3 | ||
|---|---|---|---|
| Catalog: | Level 1 (B5700-6), Level 2 (B5700-7), Level 3 (B5700-8) | ||
| Manufacturer: | BaxterDiagnostics, Inc., Deerfield, IL 60015-4633 | ||
| Analytes: | ACET, AMI, CARB, DIG, DISO, ETHO, GENT, LIDO, NAPA, PHENO, PHENY, PRIM, PROC, QUIN, SAL, THEO, hTSH, T4, TOB, T3, TU, VAL | ||
| Product: | Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls, Low and High Levels | ||
| Catalog: | Low (2841-31), High (2842-31) | ||
| Manufacturer: | Instrumentation Laboratory Company, Lexington, MA 02173-3190 | ||
| Analytes: | METH, VANCO | ||
| Product: | Abbott REA Ethanol Serum Control, Levels L, M, and H | ||
| Catalog: | 9545-11 | ||
| Manufacturer: | Abbott Laboratories, Abbott Park, IL 60064 | ||
| Analytes: | ETOH | ||
| 4. Product Description: DOCUMENT® TDM ULTRA Assayed Controls consist of three levels of a human serum matrix containing 25 commonly monitored analytes. 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 blood acetaminophen (ACET), amikacin (AMI), carbamazepine (CARB), digoxin (DIG), disopyramide (DISO), ethanol (ETOH), ethosuximide (ETHO), gentamicin (GENT) |
- e lidocaine (LIDO), methotrexate (METH), N-acetylprocainamide (NAPA), phenobarbital (PHENO), phenytoin (PHENY), primidone (PRIM), procainamide (PROC), quinidine (QUIN), salicylate (SAL), theophylline (THEO), thyroid-stimulating hormone (hTSH), thyroxine (T4), tobramycin (TOB), triiodothyronine (T3), T-Uptake (TU), valproic acid (VAL), and vancomycin (VANCO).
-
- 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
-
- Comparison to the Predicate Device:
| Characteristic | DOCUMΕΝΓΕ
TDM ULTRA
Assayed Control | Dade
Immunoassay
Comprehensive
Tri-Level Control | Instrumentation
Laboratories
TheraChem TDC
Therapeutic Drug
Control | Abbott REA
Ethanol Serum
Control |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | To assess the
analytical
performance of
analytical systems
in the quantitative
measurement of
therapeutic drugs,
thyroid function,
and ethanol | Assist in
monitoring
accuracy and
precision in
clinical assays | Control material
for procedures
used to quantitate
levels of
therapeutic drugs
and thyroid
hormones in
serum specimens | Controls for the
validation of
calibration of the
REA Ethanol
assay on the
TDxFLx, TDx, or
ADx |
| Number of Levels | Three (3):
Level I, Level II
Level III | Three (3):
Level 1, Level 2,
Level 3 | Two (2):
Low, High | Three (3):
L, M, H |
| Type | Assayed | Assayed | Assayed | Assayed |
| Analytes | 25 | 64 | 30 | 1 |
| Volume | 5 mL | 5 mL | 5 mL | 4 mL |
| Matrix | Human serum,
Liquid | Human source,
Lyophilized | Bovine serum,
Lyophilized | Human blood
components,
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 | 30 Days | Varies with
analyte following
reconstitution | Up to four weeks
after
reconstitution | Until Expiration
Date |
3
7.Test Results: The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the DOCUMENT TDM ULTRA Assayed Control to that of Dade Immunoassay Controls Comprehensive Tri-Level, Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls and Abbott REA Ethanol Serum Control. The results show that the DOCUMENT*TDM ULTRA Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes.