D1 Industry Questions and Government Answers Source Sought_Responses_Completed.docx
DOCX document 30 KB Posted
- Attached to
- Drug Testing Kits
- Solicitation number
- M00263-25-Q-MCRC
- Issued by
-
United States Marine Corps
About this file
This document is a set of Industry Questions and Government Answers for a Source Sought notice related to Drug Testing Kits for the United States Marine Corps. The solicitation (M00263-25-Q-MCRC) seeks drug test kits for six Marine Corps Districts, to be delivered to eight Recruiting Stations on a quarterly basis. The government is seeking drug testing capabilities with specific requirements, including testing for various substances such as amphetamines, benzodiazepines, cannabinoids, synthetic cannabinoids, and cocaine metabolites, with precise cut-off levels ranging from 10-500 ng/mL.
Key technical specifications include: requiring made-in-America products, FDA 510K clearance (with some flexibility for forensic use only devices), ability to record test results, and specific adulterant testing. The current incumbent device is a DrugCheck NxScan OnSite kit. The anticipated award and start date is December 2025, with delivery orders expected to be issued quarterly to the specified Marine Corps Districts. Vendors must be prepared to provide all materials, equipment, personnel, and facilities necessary for manufacturing and delivering the drug test kits to the specified locations.
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Other files
| File | Type | Posted |
|---|---|---|
| A1 Requirements Description (SOW)_Source Sought.pdf | ||
| SOURCE SOUGHT NOTICE ONLY.pdf | ||
| RS Addresses Drug Test Kits.pdf |
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Industry Questions and Government Answers MCRC Source of Sought - M00263-25-MCRC Drug Testing Kits
1. INDUSTRY QUESTION:
a). Please clarify the What cut-off level would be needed for the synthetic cannabinoids? Is it 1.0 of 1 ng/mL?
b). Please specify which cocaine metabolites to be tested?
c). Confirming that fentanyl is needed at a cut-off level of 1 ng/mL?
1): GOVERNMENT ANSWER:
a) 1ng/ml
b) Cocaine Metabolites (Benzoylecgonine)
c) Opioids (Fentanyl / Non Fentanyl) cutoff 1ng/ml
2. INDUSTRY QUESTION:
a). Are looking for urine drug test capabilities or to test actual drug/unknown items?
b). Could you provide which designer amphetamines you are looking to test for along with cut off level or would it still be 500 ng/mL?
2): GOVERNMENT ANSWER:
a) Please explain what the difference between the two.
b) Designer Amphetamines
a. 3,4-Methylenedioxymethamphetamine
b. 3,4-Methylenedioxyamphetamine
3. INDUSTRY QUESTION:
a). Can you specify what do you mean by photocopiable labels?
b). The cutoff levels stated are not typical so i just wanted to make sure they are correct?
Listed below are the typical cutoff levels for the ones I found to be low on your list.
· Amphetamines(AMP): 100 ng/mL FDA approved cutoff level is 500ng/ml and 1000ng/ml
· Benzodiazepines(BZO): 100 ng/ml FDA approved cutoff level is 300ng/ml
· Cannabinoids (Marijuana) (THC): 15 ng/mL (weed) FDA approved cutoff level is 50ng/ml
· Synthetic Cannabinoids: 1.0 ng/mL (man-made weed-like drugs) FUO FOR FORENSIC USE cutoff level is 50ng/ml
· Cocaine Metabolites: 100 ng/mL (cocaine breakdown products) FDA approved cutoff level is 150ng/ml and 300ng/ml
· Are these the levels you will be testing?
c). Would it be a possibility of an upfront payment to initiate work?
3): GOVERNMENT ANSWER:
a) We would like the ability to record the results for later review.
b) Initial Screening testing levels:
a. Amphetamines(AMP): 500ng/ml
b. Benzodiazepines(BZO): 200 ng/ml
c. Cannabinoids (Marijuana) (THC): 15 ng/mL
d. Synthetic Cannabinoids: 10 ng/mL
e. Cocaine Metabolites: 150ng/ml
c) No
4. INDUSTRY QUESTION:
a). What adulterants are you wanting on the test cup?
b). Are you requiring made in America?
c). Can you provide the CAP Master List you refer to under Accuracy and Reliability #3?
d). How will you handle a vendor's cup that doesn't have FDA 510K on all the drugs with required cutoffs level?
I just checked with our Director of Product Operations and Development, and if one of the drugs with the specific cutoff you requested, does not have an FDA 510k the device is not considered 510K cleared. It would be labeled for Forensic Use Only (FUO).
Some of the drugs and the cutoffs you are requesting do not have an FDA 510K.
My question is, will you accept a FUO labeled device?
4): GOVERNMENT ANSWER:
a) See below:
· Amphetamines(AMP)
· Benzodiazepines(BZO)
· Cannabinoids (Marijuana) (THC)
· Synthetic Cannabinoids
· Cocaine Metabolites
b) Yes
c) https://www.cap.org/laboratory-improvement/proficiency-testing/master-list-information
d) Yes
5). INDUSTRY QUESTION:
a). Is the MCRC currently utilizing the device requested in this opportunity?
b). Is the MCRC's current device FDA 510k cleared?
c). Would the MCRC consider a device that is for forensic use only (FFUO)?
d). What is the brand of the current cup being utilized by the MCRC?
e). What is the anticipated award date for this opportunity?
f). What is the anticipated start date for the resulting contract?
g). Can the MCRC identify what drugs they are interested in testing for under designer amphetamines?
h). Most rapid devices on the market do not have a 1-hour stability window. Would the MCRC consider a rapid device with a shorter stability window?
i). Would the MCRC consider a device that includes all requested drugs, with some at differing cutoffs than specified?
5): GOVERNMENT ANSWER:
a) Yes
b) Unsure
c) What is the difference between FDA 510K and FFUO?
d) DrugCheck NxScan OnSite
e) December 2025
f) December 2025
g) See question #2
h) Yes, 30 min would be the least acceptable
i) Yes, except for Cannabinoids (Marijuana) & Synthetic Cannabinoids: 1.0 ng/mL (man-made weed-like drugs)
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